Identity
- Trade Name
- Lock Activator FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture. FDA UDI
- Model / Reference
- CLA-001 FDA UDI
- Description
- Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture. FDA UDI
Identifiers
- Catalog Number
- CLA-001 FDA UDI
- Primary DI / UDI-DI
- 10855068008423 FDA UDI
- 510(k) Number
- K180050 FDA UDI
- FDA Product Code
- HSB FDA UDIHWC FDA UDI
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
Lock Activator by Curvafix Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
Cleared under the same submission
K180050 also covers:
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- CurvaFix® IM Implant — Curvafix Inc
- Inserter/Extractor — Curvafix 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
- Curvafix Inc
Sources (1)
- FDA UDI f2c32d3e-a7ae-4bcd-8b84-6100977733be 36 fields · synced May 30, 2026