Integra Laminoplasty System— 510(k) K150469
Substantially EquivalentSeaspine, Inc.
FDA 510(k) clearance K150469 for Integra Laminoplasty System, Substantially Equivalent on 2015-03-23. Applicant: Seaspine, Inc.. Device class: 2.
Clearance details
- Applicant
- Seaspine, Inc.
- Product code
- Code NQW
- Device class
- Class 2
- Regulation
- 21 CFR 888.3050
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Vista, CA, US
Recent devices under product code NQW
view allMore clearances from Seaspine, Inc.
view all- K231654 — NorthStar OCT System
- K142488 — SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
- K133418 — INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
- K132859 — INTEGRA FACET FIXATION SYSTEM
- K121924 — INTEGRA INTERSPINOUS PROCESS SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.