VALEO II PL OL Interbody Fusion System 037.7028
VALEO II PL OL Interbody Fusion System 037.7028 is a Class II device made by CTL Medical Corporation, cleared under FDA 510(k) K121892 on 24 Aug 2012 (1 earlier submission) and listed in FDA GUDID since 19 Sep 2023 (UDI-DI 00841732129412), active as of 22 Oct 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 | Number00841732129412 | Date19 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121892 | Date24 Aug 2012 | StatusActive |
Official records
- AccessGUDID record 00841732129412
- FDA 510(k) database K121892
- FDA 510(k) database K082801
Across registries
- FDA 510(k) K121892 decided 24 Aug 2012 Active
- FDA GUDID UDI-DI 00841732129412 listed 19 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K082801
- Cleared FDA 510(k) K121892
- Listed FDA GUDID 00841732129412
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VALEO II PL OL Interbody Fusion System
- Generic name
- Spinal implant trial
- Model / reference
- 037.7028
- Primary DI / UDI-DI
- 00841732129412
- FDA product code
- MAX
- GMDN term
- Spinal implant trial
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under General internal orthopaedic fixation system implantation kit.
- Humeca V-carrier 1.5mm, 1.5:1 6.V15-1.5/1 by Humeca B.V.
- ACUMED 80-0367 by ACUMED LLC
- NCB® 02.00024.002 by Zimmer, Inc.
- ACUMED 80-1828 by ACUMED LLC
- WI-407-005R: Non-Sterile, Reusable, Micro Ear Forceps 80Mm Shaft, 4.0 X 0.8Mm Serrated Jaw, Left by WELDON INSTRUMENTS
- Screwdriver 109.01.020 by Zimmer, Inc.
- 5150-9-960 by Stryker GmbH
- 0193-3800 by Stryker GmbH
- OsteoMed 320-1002 by Osteomed Corp.