FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)
FDA 510(k) clearance K063009 · decided 2006-12-27
Clearance details
- K-number
- K063009
- Device name
- FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)
- Applicant
- Praesidia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-02
- Decision date
- 2006-12-27
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.