Duns Number:989365556
Device Description: PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 58 PINNACLE Hip Solutions DUAL MOBILITY LINER PINNACLE Acetabular Shell BI-MENTUM PE Liner 58/49 58mm 49/28
Catalog Number
121858049
Brand Name
PINNACLE Hip Solutions
Version/Model Number
1218-58-049
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
K200854
Product Code
LPH
Product Code Name
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Public Device Record Key
8e914bc2-3ad0-41be-aa0c-93883a5f8308
Public Version Date
December 21, 2020
Public Version Number
1
DI Record Publish Date
December 11, 2020
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 | 3549 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2188 |
| 3 | A medical device with high risk that requires premarket approval | 418 |