FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Stablyx CMC Arthroplasty Implant System
K Number: K180744
·
Decision Apr 11, 2018
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
18
Review Days
20
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
- Stablyx CMC Arthroplasty Implant System
- K Number
- K180744
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3770
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skeletal Dynamics, LLC
- Date Received
- March 22, 2018
- Decision Date
- April 11, 2018
- Product Code
- KYI
- 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 |
|---|---|---|---|
| KYI | Prosthesis, Wrist, Carpal Trapezium | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYI), ordered by most recent decision date.
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
FDA 510(k)
FDA Class 2
·Orthopedic
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
FDA 510(k)
FDA Class 2
·Orthopedic
ASCENSION NUGRIP CMC IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ARTELON STT SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
ARTELON CMC SPACER ARTHRO
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Skeletal Dynamics, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K182492 | Geminus Volar Distal Radius Plate System | Oct 10, 2018 | Substantially Equivalent |
| K172688 | Align Radial Head System | Dec 22, 2017 | Substantially Equivalent |
| K171590 | Distal Elbow Plating System | Jun 27, 2017 | Substantially Equivalent |
| K153208 | Internal Joint Stabilizer - Elbow | Dec 31, 2015 | Substantially Equivalent |
| K150675 | Dorsal Spanning Plate | May 12, 2015 | Substantially Equivalent |
| K143624 | Headless Compression Screw System | Jan 13, 2015 | Substantially Equivalent |
| K140892 | DISTAL ELBOW PLATING SYSTEM | Aug 28, 2014 | Substantially Equivalent |
| K140372 | FRAGMENT PLATE SYSTEM | Apr 7, 2014 | Substantially Equivalent |
| K122310 | GEMINUS FOSSA SPECIFIC PLATE SYSTEM | Jan 18, 2013 | Substantially Equivalent |
| K122737 | GEMINUS FOSSA SPECIFIC PLATE SYSTEM | Oct 3, 2012 | Substantially Equivalent |