Identity
- Trade Name
- PAR 5 HAP HIP SYSTEM FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Model / Reference
- 21-109256 FDA UDI
Identifiers
- Catalog Number
- 21-109256 FDA UDI
- Primary DI / UDI-DI
- 00880304282131 FDA UDI
- 510(k) Number
- K022094 FDA UDI
- FDA Product Code
- LPH FDA UDIJDI FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3350 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
Par 5 Hap Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022094 also covers:
- PAR 5 HAP HIP SYSTEM — Biomet Orthopedics, Inc.
- PAR 5 HAP HIP SYSTEM — Biomet Orthopedics, Inc.
- PAR 5 HAP HIP SYSTEM — Biomet Orthopedics, Inc.
- PAR 5 HAP HIP SYSTEM — Biomet Orthopedics, Inc.
- PAR 5 HIP SYSTEM — Biomet Orthopedics, Inc.
- PAR 5 HIP SYSTEM — Biomet Orthopedics, Inc.
- PAR 5 HIP SYSTEM — Biomet Orthopedics, Inc.
- PAR 5 HIP SYSTEM — Biomet Orthopedics, Inc.
- PAR 5 HIP SYSTEM — Biomet Orthopedics, Inc.
- PAR 5 RINGLOC HIP SYSTEM — Biomet Orthopedics, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 5f85254c-faaf-49d3-b726-2bb4b0d7077b 36 fields · synced May 30, 2026