INTEGRA LAMINOPLASTY SYSTEM— 510(k) K130830
Substantially EquivalentSeaspine, Inc.
FDA 510(k) clearance K130830 for INTEGRA LAMINOPLASTY SYSTEM, Substantially Equivalent on 2013-05-09. 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
- Traditional
- Location
- Vista, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.