No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850015699108 | 110044505 | CTE Instruments are stored in an Instrument Tray which has no contact with the p CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™ te Modular Bracket, Impaction Sleeve | |
2 | 00850015699009 | 43-5399-058-14 | The Canary Medical Drill Bit is used to create the cavity in the patient’s tibia The Canary Medical Drill Bit is used to create the cavity in the patient’s tibial intramedullary canal to fit the CTE implant and cement mantle. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Cemented Tibia Drill Bit | |
3 | 00860003118351 | 43-5571-058-14 | The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Provisional | |
4 | 00850015699023 | 43-5399-051-05 | The Canary Medical Tibia Resection Cutting Guide (left or right option) is used The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. | |
5 | 00860003118313 | 43-5570-002-14 | The OR Base Station subsystem is intended to send and receive data to and from t The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery. | OUG | Medical Device Data System | 1 | Canary OR Base Station / OR PC App / OR Registration | |
6 | 00850015699078 | 43-5907-080-27 | Tibial Cutting guide is placed within a tray, held in place by reusable Modular Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. | |
7 | 00850015699030 | 110043613 | Stem provisional is placed within a tray, held in place by reusable Modular Brac Stem provisional is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Modular Bracket Stem Provisional | |
8 | 00850015699054 | 43-5399-052-05 | The Canary Medical Tibia Resection Cutting Guide (left or right option) is used The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. | |
9 | 00850015699047 | 110043614 | Drill Bit is placed within a tray, held in place by reusable Modular Brackets th Drill Bit is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Modular Bracket Drill Bit | |
10 | 00860003118337 | 43-5570-003-14 | Dedicated Laptop PC, part of the OR Base Station System | OUG | Medical Device Data System | 1 | OR Laptop | |
11 | 00860003118306 | 43-5570-058-14 | The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) S The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized during by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona Personalized Knee System. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te | |
12 | 00850015699085 | 43-5907-080-29 | Tibial Cutting guide is placed within a tray, held in place by reusable Modular Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. | |
13 | 00850015699016 | 43-5570-006-14 | After the surgery is completed, the OR Barcode Scanner can be used to scan the b After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components. | OUG | Medical Device Data System | 1 | OR Barcode Scanner | |
14 | 00850015699092 | 43-5570-004-14 | The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the s The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Canary Tibial Ext 14x58mm X-Ray Template | |
15 | 00850015699061 | 43-5399-001-14 | The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument u The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Baseplate. The Impaction Sleeve protects the implant’s electronic components from impaction forces that occur during assembly. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Impaction Sleeve |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
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1 | 00841709118319 | M9D-042 / 9A682001 | M9D-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
2 | 00841709118296 | M9-042 / 9A682001 | M9-042-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
3 | 00841709118289 | M9-041 / 9A682001 | M9-041-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
4 | 00841709118272 | M9-040 / 9A682001 | M9-040-DL | The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, cl The M9 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
5 | 00841709118241 | M11-042 / 9A682001 | M11-042-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Ritter | MIDMARK CORPORATION |
6 | 00841709118234 | M11-041 / 9A682001 | M11-041-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
7 | 00841709118227 | M11-040 / 9A682001 | M11-040-DL | The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, c The M11 Steam Sterilizer can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.The Midmark Data Logger is designed to connect with a Midmark sterilizer and electronically store sterilizer cycle data such as: sterilizer serial number, date and time the cycle was run, sterilization cycle parameters, errors and the cycle approving authority. | Midmark | MIDMARK CORPORATION |
8 | 00841492104698 | 354018 | Responder | RAULAND-BORG CORPORATION | ||
9 | 00841492104681 | 354017 | Responder | RAULAND-BORG CORPORATION | ||
10 | 00841492104667 | 354016 | Responder | RAULAND-BORG CORPORATION | ||
11 | 00841492104643 | 354015 | Responder | RAULAND-BORG CORPORATION | ||
12 | 00841492104612 | 354012 | Responder | RAULAND-BORG CORPORATION | ||
13 | 00841492104582 | 354011 | Responder | RAULAND-BORG CORPORATION | ||
14 | 00841492104575 | 354010 | Responder | RAULAND-BORG CORPORATION | ||
15 | 00841492104568 | 354002 | Responder | RAULAND-BORG CORPORATION | ||
16 | 00841492104513 | 354001WP | Responder | RAULAND-BORG CORPORATION | ||
17 | 00841492104490 | 354001 | Responder | RAULAND-BORG CORPORATION | ||
18 | 00841492104476 | 354000 | Responder | RAULAND-BORG CORPORATION | ||
19 | 00841492104452 | 353200 | Responder | RAULAND-BORG CORPORATION | ||
20 | 00841492104445 | 353101 | Responder | RAULAND-BORG CORPORATION | ||
21 | 00841492104438 | 353100 | Responder | RAULAND-BORG CORPORATION | ||
22 | 00841492104421 | 353010 | Responder | RAULAND-BORG CORPORATION | ||
23 | 00841492104384 | 353001 | Responder | RAULAND-BORG CORPORATION | ||
24 | 00841492104360 | 353000 | Responder | RAULAND-BORG CORPORATION | ||
25 | 00841492104353 | 352021 | Responder | RAULAND-BORG CORPORATION | ||
26 | 00841492104339 | 352010 | Responder | RAULAND-BORG CORPORATION | ||
27 | 00841492104322 | 352004 | Responder | RAULAND-BORG CORPORATION | ||
28 | 00841492104308 | 352000 | Responder | RAULAND-BORG CORPORATION | ||
29 | 00841492104285 | 351310 | Responder | RAULAND-BORG CORPORATION | ||
30 | 00841492104261 | 351300 | Responder | RAULAND-BORG CORPORATION | ||
31 | 00841492104254 | 351205 | Responder | RAULAND-BORG CORPORATION | ||
32 | 00841492104186 | 351004 | Responder | RAULAND-BORG CORPORATION | ||
33 | 00841492104179 | 351003 | Responder | RAULAND-BORG CORPORATION | ||
34 | 00841492104155 | 351001 | Responder | RAULAND-BORG CORPORATION | ||
35 | 00841492104148 | 351000 | Responder | RAULAND-BORG CORPORATION | ||
36 | 00841492104094 | 350300 | Responder | RAULAND-BORG CORPORATION | ||
37 | 00841492104087 | 350034 | Responder | RAULAND-BORG CORPORATION | ||
38 | 00841492103899 | 3225300 | Responder | RAULAND-BORG CORPORATION | ||
39 | 00841492103806 | 301103 | Responder | RAULAND-BORG CORPORATION | ||
40 | 00841492102564 | R5KURTA | Responder | RAULAND-BORG CORPORATION | ||
41 | 00841492102557 | R5KUPS1 | Responder | RAULAND-BORG CORPORATION | ||
42 | 00841492102533 | R5KUPB2 | Responder | RAULAND-BORG CORPORATION | ||
43 | 00841492102526 | R5KUCNL | Responder | RAULAND-BORG CORPORATION | ||
44 | 00841492102502 | R5KSSTF | Responder | RAULAND-BORG CORPORATION | ||
45 | 00841492102496 | R5KSMST | Responder | RAULAND-BORG CORPORATION | ||
46 | 00841492102489 | R5KSDTY | Responder | RAULAND-BORG CORPORATION | ||
47 | 00841492102472 | R5KPS1V | Responder | RAULAND-BORG CORPORATION | ||
48 | 00841492102465 | R5KPS1LCA | Responder | RAULAND-BORG CORPORATION | ||
49 | 00841492102458 | R5KPS1EA | Responder | RAULAND-BORG CORPORATION | ||
50 | 00841492102441 | R5KPS1A | Responder | RAULAND-BORG CORPORATION |