BONE SOURCE HYDROXYAPATITE— 510(k) K970400
Substantially EquivalentOrthofix, Inc.
FDA 510(k) clearance K970400 for BONE SOURCE HYDROXYAPATITE, Substantially Equivalent on 1997-05-02. Applicant: Orthofix, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthofix, Inc.
- Product code
- Code LZK
- Device class
- Class 2
- Regulation
- 21 CFR 878.3550
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richardson, TX, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.