FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFX Femoral Implant With Inserter
K Number: K161033
·
Decision Aug 3, 2016
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
22
Review Days
112
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Basic Information
- Device Name
- AFX Femoral Implant With Inserter
- K Number
- K161033
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cayenne Medical, Inc.
- Date Received
- April 13, 2016
- Decision Date
- August 3, 2016
- Product Code
- MBI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
| K180274 | Ventix Link Knotless Anchor with Inserter | Mar 21, 2018 | Substantially Equivalent |
| K172186 | BioWick X Implant with Driver | Oct 16, 2017 | Substantially Equivalent |
| K151068 | SureLock W Suture Anchor | Jul 24, 2015 | Substantially Equivalent |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles | Mar 25, 2015 | Substantially Equivalent |
| K143392 | Quattro Bolt Tenodesis Screw | Jan 23, 2015 | Substantially Equivalent |
| K132867 | SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM | Dec 30, 2013 | Substantially Equivalent |
| K131325 | QUATTRO GL SUTURE ANCHOR | Aug 16, 2013 | Substantially Equivalent |
| K122314 | QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY | Oct 31, 2012 | Substantially Equivalent |
| K122463 | APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W | Oct 11, 2012 | Substantially Equivalent |
| K121413 | CROSSFIX II MEMISCAL REPAIR DEVICE | Jun 4, 2012 | Substantially Equivalent |