MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM— 510(k) K864403
Substantially EquivalentHowmedica Corp.
FDA 510(k) clearance K864403 for MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 1986-12-18. Applicant: Howmedica Corp.. Device class: 2.
Clearance details
- Applicant
- Howmedica Corp.
- Product code
- Code LXT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rutherford, NJ, US
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