Range Spinal System, Small Stature
by K2M, Inc.
510(k) K122877
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 | NumberK122877 | Date8 May 2013 | StatusActive |
Official records
- FDA 510(k) database K122877
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OSH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 5 Oct 2026
The Range Spinal System, Small Stature is an orthopedic device. It is part of the broader Range Spinal System, which includes the Denali, Denali Deformity, and Mesa Spinal Systems, as well as the Ari Anterior Vertebral Body Staples.
This device is specifically designed for small stature applications, featuring a 4.5mm size. It was authorized by the FDA under a 510(k) special clearance, with a decision date of May 8, 2013.
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