FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SnapShot Fixation System
K Number: K143037
·
Decision Jan 20, 2015
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
230
Applicant Total
83
Review Days
90
Basic Information
- Device Name
- SnapShot Fixation System
- K Number
- K143037
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOMET MANUFACTURING CORP.
- Date Received
- October 22, 2014
- Decision Date
- January 20, 2015
- Product Code
- JDR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDR), ordered by most recent decision date.
Linkt Compression Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex DynaNite Nitinol Staples
FDA 510(k)
FDA Class 2
·Orthopedic
TMC Compression Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
TMC Compression Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
COGNiTiON Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by BIOMET MANUFACTURING CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K152754 | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) | May 16, 2016 | Substantially Equivalent |
| K153558 | Ventix Suture Anchor | Apr 21, 2016 | Substantially Equivalent |
| K152262 | Ventix Knotless Anchors | Mar 8, 2016 | Substantially Equivalent |
| K152868 | ExpressBraid Graft Manipulation | Feb 8, 2016 | Substantially Equivalent |
| K153398 | Comprehensive SRS/Nexel Elbow | Feb 3, 2016 | Substantially Equivalent |
| K151615 | TiTHON Staple with OsseoTi Technology | Oct 2, 2015 | Substantially Equivalent |
| K150768 | JuggerKnot Soft Anchors | Sep 4, 2015 | Substantially Equivalent |
| K150424 | JuggerStitch Meniscal Repair Device | May 15, 2015 | Substantially Equivalent |
| K143188 | 3.Omm Biomet Cannulated Screw System | Dec 30, 2014 | Substantially Equivalent |
| K141263 | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS | Nov 19, 2014 | Substantially Equivalent |