No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00850004435052 | SA002-55 | OsteoFab 5.5mm Suture Anchor | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | OsteoFab Suture Anchor | ||
2 | 00850004435045 | SA002-45 | OsteoFab 4.5mm Suture Anchor | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | OsteoFab Suture Anchor | ||
3 | 00850004435038 | INS002-01-003 | 4mm OsteoFab Suture Anchor Awl | HWJ | Awl | 1 | OsteoFab Suture Anchor | |
4 | 00850004435069 | SA002-65 | OsteoFab 6.5mm Suture Anchor | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | OsteoFab Suture Anchor | ||
5 | 00850004435021 | INS002-01-002 | 3mm OsteoFab Suture Anchor Awl | HWJ | Awl | 1 | OsteoFab Suture Anchor | |
6 | 00850004435014 | INS002-01-001 | 2mm OsteoFab Suture Anchor Awl | HWJ | Awl | 1 | OsteoFab Suture Anchor | |
7 | 00850004435007 | INS002-02-001 | OsteoFab Suture Anchor Inserter | MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | OsteoFab Suture Anchor | |
8 | 00810023928638 | PK623880 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
9 | 00810077245729 | PK625175 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
10 | 00810077245071 | PK625047 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
11 | 00810077245880 | PK625217 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
12 | 00810077246306 | PK625249 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
13 | 00810077244746 | PK625004 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
14 | 00810077243855 | PK624832 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
15 | 00810077243404 | PK624788 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
16 | 00810077242582 | PK624637 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
17 | 00810077242513 | PK624627 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
18 | 00810077242445 | PK624608 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
19 | 00810077242377 | PK624599 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
20 | 00810077242353 | PK624591 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
21 | 00810077242346 | PK624590 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
22 | 00810077240175 | PK624150 | KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | HTR-PEKK | ||
23 | 00810023929031 | PK623997 | KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | HTR-PEKK | ||
24 | 00810023929161 | PK624032 | KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | HTR-PEKK | ||
25 | 00810077245910 | PK625170 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
26 | 00810077245903 | PK625169 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
27 | 00810077245897 | PK625216 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
28 | 00810077245217 | PK625076 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
29 | 00810077245200 | PK625078 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
30 | 00810077245194 | PK625074 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
31 | 00810077245187 | PK625070 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
32 | 00810077245583 | PK625151 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
33 | 00810077245545 | PK625141 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
34 | 00810077245767 | PK625184 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
35 | 00810077245750 | PK625181 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
36 | 00810077245743 | PK625159 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
37 | 00810077245736 | PK625179 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
38 | 00810077245712 | PK625162 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
39 | 00810077245705 | PK625142 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
40 | 00810077245699 | PK625172 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
41 | 00810077245682 | PK625163 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
42 | 00810077245675 | PK625156 | GXN,KKY | Plate, Cranioplasty, Preformed, Non-Alterable,Material, Polytetrafluoroethylene Plate, Cranioplasty, Preformed, Non-Alterable,Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | HTR-PEKK | ||
43 | 00810077245668 | PK625129 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
44 | 00810077245651 | PK625168 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
45 | 00810077245644 | PK625160 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
46 | 00810077245088 | PK625037 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
47 | 00810077244708 | PK624995 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
48 | 00810077244692 | PK625001 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
49 | 00810077244678 | PK624992 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK | ||
50 | 00810077244661 | PK624990 | GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | HTR-PEKK |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M384815791US0 | 81-5791[US] | 81-5791[US] | Mesh Plate - Ø1.9 mm | Bioplate® | BIOPLATE, INC. |
2 | M384815791CP0 | 81-5791-CP | 81-5791-CP | Mesh Plate - Ø1.9 mm | Bioplate® | BIOPLATE, INC. |
3 | M3848157910 | 81-5791 | 81-5791 | Mesh Plate - Ø1.9 mm | Bioplate® | BIOPLATE, INC. |
4 | M3848135960 | 81-3596 | 81-3596 | 5-Tab Zip Implant - 20 mm | Bioplate@ | BIOPLATE, INC. |
5 | M384813595US0 | 81-3595[US] | 81-3595[US] | 5-Tab Zip Implant - 16 mm | Bioplate@ | BIOPLATE, INC. |
6 | M3848135950 | 81-3595 | 81-3595 | 5-Tab Zip Implant - 16 mm | Bioplate@ | BIOPLATE, INC. |
7 | M3848135940 | 81-3594 | 81-3594 | 5-Tab Zip Implant - 12 mm | Bioplate@ | BIOPLATE, INC. |
8 | M3848135180 | 81-3518 | 81-3518 | Zip® Implant - 20 mm (STERILE) [6 PK] | Bioplate@ | BIOPLATE, INC. |
9 | M3848135170 | 81-3517 | 81-3517 | Zip® Implant - 16 mm (STERILE) [6 PK] | Bioplate@ | BIOPLATE, INC. |
10 | M3848135160 | 81-3516 | 81-3516 | Zip® Implant - 12 mm (STERILE) [6 PK] | Bioplate@ | BIOPLATE, INC. |
11 | M3848134980 | 81-3498 | 81-3498 | Zip® Implant, 18 mm diam. | Bioplate® | BIOPLATE, INC. |
12 | M3848134970 | 81-3497 | 81-3497 | Zip® Implant, 15 mm diam. | Bioplate® | BIOPLATE, INC. |
13 | M3848134960 | 81-3496 | 81-3496 | Zip® Implant, 11 mm diam. | Bioplate® | BIOPLATE, INC. |
14 | 07350086550115 | XL | 101011 | OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090) | OSSDSIGN Cranial PSI | OSSDSIGN AB |
15 | 07350086550108 | L | 101010 | OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090) | OSSDSIGN Cranial PSI | OSSDSIGN AB |
16 | 07350086550092 | M | 101009 | OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090) | OSSDSIGN Cranial PSI | OSSDSIGN AB |
17 | 07350086550085 | S | OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090) | OSSDSIGN Cranial PSI | OSSDSIGN AB | |
18 | 04038653402243 | FF492T | FF492T | CRANIOFIX 2 TITANIUM CLAMP 20MM | CRANIOFIX2 | AESCULAP AG |
19 | 04038653379620 | FF494R | FF494R | CRANIOFIX2 Applier, 8", (205 mm), non-sterile, reusable | AESCULAP | AESCULAP AG |
20 | 04038653379583 | FF491T | FF491T | CRANIOFIX 2 TITANIUM CLAMP 16MM | CRANIOFIX2 | AESCULAP AG |
21 | 04038653379576 | FF490T | FF490T | CRANIOFIX 2 TITANIUM CLAMP 11MM | CRANIOFIX2 | AESCULAP AG |
22 | 04038653163083 | FF105R | FF105R | CRANIOFIX2 Holding Forceps, angled, 4 1/2", (115 mm), non-sterile, reusable | AESCULAP | AESCULAP AG |
23 | 04038653163076 | FF104R | FF104R | CRANIOFIX2 Removal Forceps, 5 1/8", (130 mm), non-sterile, reusable | AESCULAP | AESCULAP AG |
24 | 04038653163069 | FF103R | FF103R | CRANIOFIX2 Cutting Forceps, 5 3/4", (145 mm), non-sterile, reusable | AESCULAP | AESCULAP AG |
25 | 00888233027106 | PK623342 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | ||
26 | 00888233027090 | PK623340 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | ||
27 | 00888233027083 | PK623325 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | ||
28 | 00888233027076 | PK623302 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | ||
29 | 00888233027069 | PK623247 | HTR-PEKK | OXFORD PERFORMANCE MATERIALS, INC. | ||
30 | 00888233011273 | 75-1040-12 | 75-1040-12 | RAPIDFLAP (TM) SYSTEM | BIOMET MICROFIXATION, INC | |
31 | 00888233011259 | 75-1030-12 | 75-1030-12 | RAPIDFLAP (TM) SYSTEM | BIOMET MICROFIXATION, INC | |
32 | 00888233011235 | 75-1020-12 | 75-1020-12 | RAPIDFLAP (TM) SYSTEM | BIOMET MICROFIXATION, INC | |
33 | 00888118120595 | 60-001-94-09 | IMPLANT, MIDFACE, 00194, PEEK | IPS | KLS-MARTIN L.P. | |
34 | 00888118106353 | 993-03-8778 | PEEK, LARGE, PEEK | IPS | KLS-MARTIN L.P. | |
35 | 00888118106018 | 993-03-8943 | IPS, PEEK, PEEK | IPS | KLS-MARTIN L.P. | |
36 | 00888118105653 | 993-02-8770 | PEEK, PEEK | IPS | KLS-MARTIN L.P. | |
37 | 00888118100900 | 60-000-89-09 | IMPLANT, CRANIAL, 00089, CP TITANIUM | IPS | KLS-MARTIN L.P. | |
38 | 00888118100894 | 60-000-88-09 | IMPLANT, CRANIAL, 00088, CP TITANIUM | IPS | KLS-MARTIN L.P. | |
39 | 00888118100887 | 60-000-87-09 | IMPLANT, CRANIAL, 00087, CP TITANIUM | IPS | KLS-MARTIN L.P. | |
40 | 00888118100870 | 60-000-86-09 | IMPLANT, CRANIAL, INDIVIDUAL, 00086, CP TITANIUM | IPS | KLS-MARTIN L.P. | |
41 | 00888118100764 | 60-000-74-09 | IMPLANT, MANDIBLE, CRIB MESH, 00074, 1.5 MM SCREW, TI-6AL-4V | IPS | KLS-MARTIN L.P. | |
42 | 00888118100634 | 60-000-61-09 | IMPLANT, CRANIAL, 00061, TI-6AL-4V | IPS | KLS-MARTIN L.P. | |
43 | 00888118100627 | 60-000-60-09 | IMPLANT, CRANIAL, 00060, TI-6AL-4V | IPS | KLS-MARTIN L.P. | |
44 | 00888118100610 | 60-000-59-09 | IMPLANT, CRANIAL, 00059, TI-6AL-4V | IPS | KLS-MARTIN L.P. | |
45 | 00888118100603 | 60-000-58-09 | IMPLANT, CRANIAL, 00058, TI-6AL-4V | IPS | KLS-MARTIN L.P. | |
46 | 00888118100559 | 60-000-53-09 | IMPLANT, CRANIAL, INDIVIDUAL, 00053, TI-6AL-4V | IPS | KLS-MARTIN L.P. | |
47 | 00888118100535 | 60-000-43-09 | IMPLANT, MIDFACE, ONLAY, 00043, PEEK | IPS | KLS-MARTIN L.P. | |
48 | 00888118100511 | 60-000-42-09 | IMPLANT, MANDIBLE, ONLAY, 00042, PEEK | IPS | KLS-MARTIN L.P. | |
49 | 00888118100498 | 60-000-41-09 | IMPLANT, MANDIBLE, ONLAY, 00041, PEEK | IPS | KLS-MARTIN L.P. | |
50 | 00888118100481 | 60-000-40-71 | IMPLANT, CRANIAL, ONLAY, 00040, PEEK | IPS, STERILE | KLS-MARTIN L.P. |