Identity
- Trade Name
- PROFYLE FDA UDI
- Generic Name
- Surgical countersink, single-use FDA UDI
- Device Name
- COUNTERSINK F. CROSS-FIT SCREWS, AO-S. FDA UDI
- Model / Reference
- 60-80317 FDA UDI
- Description
- COUNTERSINK F. CROSS-FIT SCREWS, AO-S. FDA UDI
Identifiers
- Catalog Number
- 60-80317 FDA UDI
- Primary DI / UDI-DI
- 04546540251879 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Surgical countersink, single-use 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
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
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
Dimensions & Sizes
- Size
- Length — 47.0 Millimeter FDA UDI
Category: Surgical countersink, single-use
A medical device designed to enlarge the diameter of a hole drilled in bone, used to recess screws/bolts within bone or accommodate implantation devices. The Profyle is a single-use surgical instrument intended for use with AO-S instruments.
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
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc. · Class II
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED · Class I
- CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc. · Class II
- FuzeFix Mini — FUSION ORTHOPEDICS, LLC · 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
- Stryker Corp.
Sources (1)
- FDA UDI c9cfd4d9-efe9-46c6-98c2-1e5fe00a8043 35 fields · synced Jul 15, 2026