GUIDED GROWTH SYSTEM— 510(k) K093442
Substantially EquivalentOrthofix, Inc.
FDA 510(k) clearance K093442 for GUIDED GROWTH SYSTEM, Substantially Equivalent on 2010-06-10. Applicant: Orthofix, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthofix, Inc.
- Product code
- Code OBT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mckinney, TX, US
Recent devices under product code OBT
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- K210667 — FIREBIRD SI Fusion System
- K203342 — CONSTRUX Mini Ti Spacer System
Data sourced from openFDA. This site is unofficial and independent of the FDA.