Identity
- Trade Name
- PINNACLE FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- PINNACLE TRI-FLANGE ACETABULAR CUP W/HA SIZE: 66mm RIGHT FOR CEMENTLESS USE ONLY FDA UDI
- Model / Reference
- 1217-99-096 FDA UDI
- Description
- PINNACLE TRI-FLANGE ACETABULAR CUP W/HA SIZE: 66mm RIGHT FOR CEMENTLESS USE ONLY FDA UDI
Identifiers
- Catalog Number
- 121799096 FDA UDI
- Primary DI / UDI-DI
- 10603295445845 FDA UDI
- 510(k) Number
- K040383 FDA UDI
- FDA Product Code
- LPH FDA UDIMEH FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acetabular shell
Pinnacle by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Acetabular shell.
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Cleared under the same submission
K040383 also covers:
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
- PINNACLE — DEPUY ORTHOPAEDICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 02df5f00-3c55-4e94-89a2-dafff90082d9 36 fields · synced Jun 8, 2026