Duns Number:080506581
Device Description: PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF061521.007) FOR CEMENTLESS USE ONLY PATIENT SP PINNACLE TRI-FLANGE ACETABULAR CUP W/ HA (TF061521.007) FOR CEMENTLESS USE ONLY PATIENT SPECIFIC MEDICAL DEVICE 56MM LEFT CEMENTLESS
Catalog Number
121798375
Brand Name
PINNACLE
Version/Model Number
1217-98-375
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K040383
Product Code
LPH
Product Code Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Public Device Record Key
224c5bb6-9677-4a8a-94e6-e5aea788b163
Public Version Date
January 07, 2022
Public Version Number
1
DI Record Publish Date
December 30, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
| 3 | A medical device with high risk that requires premarket approval | 908 |