Identity
- Trade Name
- REUNITE PLATING SYSTEM FDA UDI
- Generic Name
- Orthopaedic fixation plate, bioabsorbable FDA UDI
- Model / Reference
- 948480 FDA UDI
Identifiers
- Catalog Number
- 948480 FDA UDI
- Primary DI / UDI-DI
- 00880304424432 FDA UDI
- FDA Product Code
- MAI FDA UDIHRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, 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 fixation plate, bioabsorbable
Reunite Plating System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, bioabsorbable.
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- CENTRALOC TIBIAL FIXATION — Biomet Sports Medicine · Class II
- 1.5 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
Cleared under the same submission
K964970 also covers:
- REUNITE PLATING SYSTEM — Biomet Orthopedics, Inc.
- REUNITE PLATING SYSTEM — Biomet Orthopedics, Inc.
- REUNITE PLATING SYSTEM — Biomet Orthopedics, Inc.
- REUNITE PLATING SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
K991763 also covers:
- REUNITE PLATING SYSTEM — Biomet Orthopedics, Inc.
- REUNITE PLATING SYSTEM — Biomet Orthopedics, Inc.
- REUNITE PLATING SYSTEM — Biomet Orthopedics, Inc.
- REUNITE PLATING SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc.
- REUNITE SCREW 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 a0706775-9cc7-4531-ba12-9d62bd8a7d60 36 fields · synced May 31, 2026