Small Stature Spacers
510(k) K063393
Small Stature Spacers is a Class II device made by Biomet Spine LLC, cleared under FDA 510(k) K063393 on 25 Jun 2007, 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 | NumberK063393 | Date25 Jun 2007 | StatusActive |
Official records
- FDA 510(k) database K063393
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQP
- FDA applicant
- Biomet Spine
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MQP (Spinal Vertebral Body Replacement Device).
- CAPRI by K2M, INC.
- PYRAMESH® C Titanium Mesh 905-901 by MEDTRONIC SOFAMOR DANEK, INC.
- CONCORDE 187823110 by MEDOS INTERNATIONAL SARL
- VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX by Stryker Spine
- TITANIUM MESH IMPLANT by Interpore Cross Intl.
- T2 STRATOSPHERE™ Expandable Corpectomy System by MEDTRONIC SOFAMOR DANEK, INC.
- BENGAL 177304211 by Depuy Spine, Inc.
- STACKABLE CAGE SYSTEM by Depuy Motech Acromed
- ATLAS SPINE VERTEBRAL BODY REPLACEMENT by ATLAS SPINE INC.
- STAXX XD SYSTEM by Spine Wave, Inc.