Identity
- Trade Name
- Flat Washer FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Model / Reference
- 110008353 FDA UDI
Identifiers
- Catalog Number
- 110008353 FDA UDI
- Primary DI / UDI-DI
- 00887868522345 FDA UDI
- 510(k) Number
- K140891 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Implantable bone washer
Flat Washer by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Implantable bone washer.
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- LEOS Cannulated Screw System — Tyber Medical · Class II
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Cleared under the same submission
K140891 also covers:
- Biomet Cannulated Screw System — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 10MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 16MM (PARTIAL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 22MM (PARTIAL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 50MM (PARTIAL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 55MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 65MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 70MM (PARTIAL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 5.0MM X 34MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 5.0MM X 34MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 5.0MM X 44MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 5.0MM X 95MM (FULL THREAD) — 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 1881ea35-74b8-41f7-8715-fec5a9504544 36 fields · synced Jun 1, 2026