SHORTENING OSTEOTOMY GUIDE— 510(k) K861576
Substantially EquivalentOsteotomy Guide Co.
FDA 510(k) clearance K861576 for SHORTENING OSTEOTOMY GUIDE, Substantially Equivalent on 1986-05-12. Applicant: Osteotomy Guide Co.. Device class: 1.
Clearance details
- Applicant
- Osteotomy Guide Co.
- Product code
- Code HTH
- Device class
- Class 1
- Regulation
- 21 CFR 888.4600
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mesa, AZ, US
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