Op Spine System
by Orthopediatrics Corp. 2 variants
510(k) K120291
Op Spine System is a Class II device made by Orthopediatrics Corp., cleared under FDA 510(k) K120291 on 16 Apr 2012, 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)SESU | NumberK120291 | Date16 Apr 2012 | StatusActive |
Official records
- FDA 510(k) database K120291
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- Withdrawn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
- SESU
Similar devices
Other devices filed under FDA product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis).
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- EXPEDIUM 179952060 by MEDOS INTERNATIONAL SARL
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- EXPEDIUM 179922000 by MEDOS INTERNATIONAL SARL
- RANGE SPINAL SYSTEM by K2M, INC.
- EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM by Depuy Spine, A Johnson & Johnson Company
- OLYMPIC Posterior Spinal Fixation System by Astura Medical