Identity
- Trade Name
- Cut Screw - Percutaneous Compression Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- CUT SCREW S Ø3.0 x 18.0mm FDA UDI
- Model / Reference
- Cut Screw - Sterile FDA UDI
- Description
- CUT SCREW S Ø3.0 x 18.0mm FDA UDI
Identifiers
- Catalog Number
- 317-03-18S FDA UDI
- Primary DI / UDI-DI
- 07899258659039 FDA UDI
- 510(k) Number
- K230397 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Cut Screw - Percutaneous Compression Screw by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K230397 also covers:
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Cut Screw - Percutaneous Compression Screw — GM DOS REIS INDUSTRIA E COMERCIO LTDA
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
- Gm Dos Reis Industria E Comercio Ltda
Sources (1)
- FDA UDI 3259bcee-85c5-4eb2-a8e3-02f92f3b82f8 35 fields · synced Jun 8, 2026