Identity
- Trade Name
- REUNITE ORTHOPEDIC PIN SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone pin, bioabsorbable FDA UDI
- Model / Reference
- 948218 FDA UDI
Identifiers
- Catalog Number
- 948218 FDA UDI
- Primary DI / UDI-DI
- 00880304424258 FDA UDI
- 510(k) Number
- K990291 FDA UDI
- FDA Product Code
- MAI FDA UDIHTY FDA UDI
- GMDN Term
- Orthopaedic bone pin, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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: Orthopaedic bone pin, bioabsorbable
Reunite Orthopedic Pin System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone pin, bioabsorbable.
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- Self-Reinforced Technology — Conmed Corporation · Class II
- AESCULAP — AESCULAP, INC. · Class II
- SmartNail Self-Reinforced Technology — Conmed Corporation · Class II
- ActivaPin™ — Bioretec Oy · Class II
Cleared under the same submission
K990291 also covers:
- 1.5MM REUNITE PN INSTR — Biomet Orthopedics, Inc.
- HEAT LOOP — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN SYSTEM — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN SYSTEM — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN SYSTEM — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN SYSTEM — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN SYSTEM — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN SYSTEM — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN SYSTEM — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN SYSTEM — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN SYSTEM — Biomet Orthopedics, Inc.
- REUNITE ORTHOPEDIC PIN 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 761a1667-e117-4910-b276-fabe333165c1 36 fields · synced May 30, 2026