Ardis Interbody System
by Zimmer Spine, Inc. 2 variants
510(k) K133184
Ardis Interbody System is a Class II device made by Zimmer Spine, Inc., cleared under FDA 510(k) K133184 on 30 Jan 2014, 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 | NumberK133184 | Date30 Jan 2014 | StatusActive |
Official records
- FDA 510(k) database K133184
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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