FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
FDA 510(k) clearance K140127 · decided 2014-05-28
Clearance details
- K-number
- K140127
- Device name
- FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
- Applicant
- Pontis Orthopaedics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-01-16
- Decision date
- 2014-05-28
- Days to decision
- 132 days
- Clearance type
- Special
- Product code
- GAQ
- Device class
- 2
- Regulation number
- 878.4495
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Francisco, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.