Duns Number:080506581
Device Description: PINNACLE TRI-FLANGE ACETABULAR CUP W/O HA (TF090321.004) FOR CEMENTLESS USE ONLY PATIENT S PINNACLE TRI-FLANGE ACETABULAR CUP W/O HA (TF090321.004) FOR CEMENTLESS USE ONLY PATIENT SPECIFIC MEDICAL DEVICE 58MM RIGHT CEMENTLESS
Catalog Number
121798359
Brand Name
PINNACLE
Version/Model Number
1217-98-359
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
bf3fcf0d-8ec4-4dbb-beda-e2a23c656c53
Public Version Date
December 28, 2021
Public Version Number
1
DI Record Publish Date
December 20, 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 |