Mj-Flex 1
Mj-Flex 1 (166260) is a bone awl (FDA Class II; FDA product code HTY, Pin, Fixation, Smooth) made by Orthofix SRL, cleared under FDA 510(k) K173051 on 16 Nov 2017 and listed in FDA GUDID since 14 Apr 2018 (UDI-DI 18054242518723), active as of 12 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number18054242518723 | Date14 Apr 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173051 | Date16 Nov 2017 | StatusActive |
Official records
- AccessGUDID record 18054242518723
- FDA 510(k) database K173051
Across registries
- FDA 510(k) K173051 decided 16 Nov 2017 Active
- FDA GUDID UDI-DI 18054242518723 listed 14 Apr 2018 Listed
Timeline
- Cleared FDA 510(k) K173051
- Listed FDA GUDID 18054242518723
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mj-Flex
- Generic name
- Bone awl, reusable
- Model / Ref / Catalog
- 1, 166260
- Primary DI / UDI-DI
- 18054242518723
- 510(k) Number
- FDA product code
- HTY
- GMDN term
- Bone awl, reusable
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Bone awl, reusable.
- CODA™ Anterior Cervical Plate System 58-202220400 2022-20-400 by Pioneer Surgical Technology Inc.
- TaperFit Cemented Hip System 340.317 by CORIN LTD
- MicroFrance® M823C by Integra Microfrance
- CONMED MFX-0HV by Conmed Corporation
- 6002-700-000 by Stryker Leibinger
- Aida® awl bowed 80071024 by implantcast GmbH
- SMR Shoulder 9013.55.001 by Limacorporate
- MicroFrance® M823E by Integra Microfrance
- 2351-0011 by Stryker GmbH
- TORNIER PERFORM™ HUMERAL SYSTEM MWX340 by TORNIER, INC.