ESCALATE LAMINOPLASTY SYSTEM— 510(k) K113802
Substantially EquivalentStryker Spine
FDA 510(k) clearance K113802 for ESCALATE LAMINOPLASTY SYSTEM, Substantially Equivalent on 2012-04-16. Applicant: Stryker Spine. Device class: 2.
Clearance details
- Applicant
- Stryker Spine
- 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
- Allendale, NJ, US
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