FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
K Number: K140127
·
Decision May 28, 2014
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
31
Applicant Total
2
Review Days
132
Basic Information
- Device Name
- FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
- K Number
- K140127
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PONTIS ORTHOPAEDICS, LLC
- Date Received
- January 16, 2014
- Decision Date
- May 28, 2014
- Product Code
- GAQ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | FDA class 2 | General, Plastic Surgery |
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Other Clearances by PONTIS ORTHOPAEDICS, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K133579 | MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS | Jun 26, 2014 | Substantially Equivalent |