Identity
- Trade Name
- PRELUDE PATELLO-FEMORAL SYSTEM FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block, reusable FDA UDI
- Model / Reference
- 110004105 FDA UDI
Identifiers
- Catalog Number
- 110004105 FDA UDI
- Primary DI / UDI-DI
- 00880304566866 FDA UDI
- 510(k) Number
- K143543 FDA UDI
- FDA Product Code
- KRR FDA UDI
- GMDN Term
- Orthopaedic implant aiming/guiding block, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant aiming/guiding block, reusable
Prelude Patello-Femoral System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant aiming/guiding block, reusable.
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Cleared under the same submission
K143543 also covers:
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL SYSTEM — Biomet Orthopedics, Inc.
- PRELUDE PATELLO-FEMORAL 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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 39c7501d-ca17-42b2-84bc-f8d9738d8e64 36 fields · synced May 30, 2026