LnK Spinal Instrument System LS01-CM109
Ref LS01-CM109
LnK Spinal Instrument System LS01-CM109 is a Class I device made by L&K Biomed Co., Ltd., registered in EUDAMED on 31 Oct 2026 (Basic UDI-DI B-08800108696653) and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 08800108696653), active as of 7 Nov 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-08800108696653 08800108696653 | Date31 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number08800108696653 | Date15 Jun 2023 | StatusListed |
Official records
- EUDAMED public site B-08800108696653
- AccessGUDID record 08800108696653
Across registries
- EUDAMED Basic UDI-DI B-08800108696653 registered 31 Oct 2026 Active
- FDA GUDID UDI-DI 08800108696653 listed 15 Jun 2023 Listed
Timeline
- Listed FDA GUDID 08800108696653
- Registered EUDAMED B-08800108696653
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- LnK Spinal Instrument System
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / Ref / Catalog
- LS01-CM109
- Primary DI / UDI-DI
- 08800108696653
- Basic UDI-DI
- B-08800108696653
- FDA product code
- LXH
- EMDN code
- L098099 Orthopaedic and traumatological surgery instruments, reusable - other accessories
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- System or procedure pack
- System which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- Spain
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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