Arx Spinal System
510(k) K051525
Arx Spinal System is a Class II device made by Amedica Corp., cleared under FDA 510(k) K051525 on 17 Feb 2006, 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 | NumberK051525 | Date17 Feb 2006 | StatusActive |
Official records
- FDA 510(k) database K051525
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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- Pyramesh® Implant System 905-903 by MEDTRONIC SOFAMOR DANEK, INC.
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- KONG-C VBR System, Footprint Trial 18, 18x14 mm 43-061 by icotec AG
- BENGAL 177308213 by Depuy Spine, Inc.
- CONCORDE 187831208 by MEDOS INTERNATIONAL SARL