Identity
- Trade Name
- BITE COMPRESSION SCREWS FDA UDI
- Generic Name
- Surgical countersink, single-use FDA UDI
- Device Name
- CANNULATED COUNTERSINK, 3.0/3.5MM BITE COMPRESSION SCREW, QUICK CONNECT FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- CANNULATED COUNTERSINK, 3.0/3.5MM BITE COMPRESSION SCREW, QUICK CONNECT FDA UDI
Identifiers
- Catalog Number
- 001-A-30002 FDA UDI
- Primary DI / UDI-DI
- 18056099646819 FDA UDI
- 510(k) Number
- K132893 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical countersink, single-use 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: Surgical countersink, single-use
Bite Compression Screws by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical countersink, single-use.
- Volition Plating System — ORTHO SOLUTIONS HOLDINGS LIMITED · Class I
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class I
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED · Class I
- CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- FuzeFix Mini — FUSION ORTHOPEDICS, LLC · Class II
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- Dyna Locking Cannulated Screw — CG MedTech Co., Ltd. · Class I
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI 91189695-69b3-481b-b482-3d942cab38fa 37 fields · synced Jun 6, 2026