Enspire Debrider System
by Spine View, Inc. 2 variants
510(k) K110992
Enspire Debrider System is a Class II device made by Spine View, Inc., cleared under FDA 510(k) K110992 on 21 Oct 2011, 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 | NumberK110992 | Date21 Oct 2011 | StatusActive |
Official records
- FDA 510(k) database K110992
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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