Identity
- Trade Name
- DISTAL TIBIAL PLATE HANDLE, RIGHT FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Model / Reference
- 8163-01-003 FDA UDI
Identifiers
- Catalog Number
- 816301003 FDA UDI
- Primary DI / UDI-DI
- 00887868449253 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical implant/trial-implant/sizer holder, reusable
Distal Tibial Plate Handle, Right by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical implant/trial-implant/sizer holder, reusable.
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- JULIET INSTRUMENTATION — Spineart · Class II
- JOURNEY II XR — Smith & Nephew, Inc. · Class II
- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
- BENCOX THR System — Corentec Co., Ltd · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 139ba369-0308-48a9-bae8-5ad89e92a4a9 34 fields · synced Jun 7, 2026