A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM— 510(k) K042458
Substantially EquivalentA.M. Surgical, Inc.
FDA 510(k) clearance K042458 for A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM, Substantially Equivalent on 2004-10-07. Applicant: A.M. Surgical, Inc.. Device class: 2.
Clearance details
- Applicant
- A.M. Surgical, Inc.
- 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
- Great Neck, NY, US
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