Venus Basic Spinal Fixation System
by L&K Biomed Co., Ltd. 2 variants
510(k) K100706
Venus Basic Spinal Fixation System is a Class II device made by L&K Biomed Co., Ltd., cleared under FDA 510(k) K100706 on 22 Jul 2010, 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 | FDA 510(k)SESE | NumberK100706 | Date22 Jul 2010 | StatusActive |
Official records
- FDA 510(k) database K100706
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation).
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- Erisma®-LP 18155540 by Clariance, Inc.
- BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) by Blackstone Medical, Inc.
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