Identity
- Trade Name
- TwistCut™ Snap-Off Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- TiAl6V4 ELI sterile FDA UDI
- Model / Reference
- 2 13 FDA UDI
- Description
- TiAl6V4 ELI sterile FDA UDI
Identifiers
- Catalog Number
- CB30013S FDA UDI
- Primary DI / UDI-DI
- 04048266150035 FDA UDI
- 510(k) Number
- K152187 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 13 Millimeter FDA UDIOuter Diameter — 2.0 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
TwistCut™ Snap-Off Screw by Merete GmbH — 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
K152187 also covers:
- Merete® CS Cortical Screw Fully Threaded — Merete GmbH
- Merete® CS Cortical Screw Fully Threaded — Merete GmbH
- Merete® CS Cortical Screw Fully Threaded — Merete GmbH
- Merete® CS Cortical Screw Partly Threaded — Merete GmbH
- Merete® CS Cortical Screw Partly Threaded — Merete GmbH
- Merete® Cannulated HCS Headless Compression Screw — Merete GmbH
- Merete® Cannulated HCS Headless Compression Screw — Merete GmbH
- Merete® Cannulated HCS Headless Compression Screw — Merete GmbH
- Merete® Cannulated HCS Headless Compression Screw — Merete GmbH
- Merete® Cannulated HCS Headless Compression Screw — Merete GmbH
- Merete® Cannulated HCS Headless Compression Screw — Merete GmbH
- Merete® Cannulated PCS Compression Screw — Merete GmbH
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
- Merete GmbH
Sources (1)
- FDA UDI a03140e4-3667-4854-a4a6-8e18b98034e9 37 fields · synced Jun 8, 2026