FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GMK EXTENSION
K Number: K142069
·
Decision Dec 2, 2014
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
39
Review Days
125
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- GMK EXTENSION
- K Number
- K142069
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medacta International
- Date Received
- July 30, 2014
- Decision Date
- December 2, 2014
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
NovoKnee (SteriKnee)
FDA 510(k)
FDA Class 2
·Orthopedic
Materialise TKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Knee
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Infinia Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titan PCK Components
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Medacta International
| K Number | Device Name | ||
|---|---|---|---|
| K160605 | MectaLIF Anterior Stand-Alone | Jul 21, 2016 | Substantially Equivalent |
| K160289 | MasterLoc Stem | May 20, 2016 | Substantially Equivalent |
| K153664 | M.U.S.T. Pedicle Screw System | Jan 19, 2016 | Substantially Equivalent |
| K151531 | MasterLoc Stem | Oct 30, 2015 | Substantially Equivalent |
| K142744 | Mecta-C TiPEEK | May 7, 2015 | Substantially Equivalent |
| K143453 | Mpact Double Mobility System | Mar 2, 2015 | Substantially Equivalent |
| K141988 | M.U.S.T PEDICLE SCREW SYSTEM | Aug 19, 2014 | Substantially Equivalent |
| K141044 | M.U.S.T. EXTENSION | Aug 18, 2014 | Substantially Equivalent |
| K140826 | GMK SPHERE EXTENSION | Jul 15, 2014 | Substantially Equivalent |
| K140361 | META-C CERVICAL PLATE | Jun 12, 2014 | Substantially Equivalent |