Zyston Straight Spacer System
510(k) K112014
Zyston Straight Spacer System is a Class II device made by Biomet Spine LLC, cleared under FDA 510(k) K112014 on 17 Oct 2011, 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 | NumberK112014 | Date17 Oct 2011 | StatusActive |
Official records
- FDA 510(k) database K112014
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- FDA applicant
- Biomet Spine
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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