Identity
- Trade Name
- BITE COMPRESSION SCREWS FDA UDI
- Generic Name
- Orthopaedic bone washer, sterile FDA UDI
- Device Name
- WASHER, 5.0MM/5.5MM HEADED COMPRESSION SCREW FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- WASHER, 5.0MM/5.5MM HEADED COMPRESSION SCREW FDA UDI
Identifiers
- Catalog Number
- 001-D-10001 FDA UDI
- Primary DI / UDI-DI
- 18056099646888 FDA UDI
- 510(k) Number
- K132893 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone washer, sterile 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bone washer, sterile
Bite Compression Screws by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone washer, sterile.
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- TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- RONDO' — Citieffe · Class II
- SURFIX — Newdeal Sas · Class II
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Cleared under the same submission
K132893 also covers:
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, Inc.
- BITE COMPRESSION SCREWS — Orthofix, 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
- Orthofix, Inc.
Sources (1)
- FDA UDI 204e6369-691b-4618-ad05-ee85dc6a4add 37 fields · synced May 30, 2026