K2M General Instruments PRO-1205-03
by VB Spine LLC
K2M General Instruments PRO-1205-03 is a Class I device made by VB Spine LLC, listed in FDA GUDID since 3 Aug 2022 (UDI-DI 10888857554382), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10888857554382 | Date3 Aug 2022 | StatusListed |
Official records
- AccessGUDID record 10888857554382
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- K2M General Instruments
- Generic name
- Torque manipulation device
- Model / Ref / Catalog
- PRO-1205-03
- Primary DI / UDI-DI
- 10888857554382
- FDA product code
- LXH
- GMDN term
- Torque manipulation device
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Angle — 105 degree
Similar devices
Other devices filed under FDA product code LXH (Orthopedic manual surgical instrument).
- Gimmi KD.1544.08 by Gimmi GmbH
- Gimmi KN.1430.21 by Gimmi GmbH
- Spine Instruments 03.51.10.0856 by Medacta International SA
- Spine Instruments 03.22.10.0178 by Medacta International SA
- Vanguard® 32-485051 by Biomet Orthopedics, Inc.
- APEX Knee System WS-10101 by OMNIlife science, Inc.
- PROXIMAL TIBIA LEFT HANDLE 2142-35-012 214235012 by Biomet Orthopedics, Inc.
- CHISEL OSTEOTOME BLADE 127x20 WITH HOLE H0050209009 by HPF SRL
- ACUMED 80-0155 by ACUMED LLC
- T-handle JMPS1029ST by Joimax GmbH