FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHMEDICA CONTINUUM HIP WITH HA COATING
K Number: K932017
·
Decision Sep 1, 1994
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
31
Review Days
493
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
- TECHMEDICA CONTINUUM HIP WITH HA COATING
- K Number
- K932017
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Techmedica, Inc.
- Date Received
- April 26, 1993
- Decision Date
- September 1, 1994
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MEH), ordered by most recent decision date.
Allure Hip Stem and Intramedullary Plugs
FDA 510(k)
FDA Class 2
·Orthopedic
Mfinity Femoral System
FDA 510(k)
FDA Class 2
·Orthopedic
Trivicta® Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Resolve Modular Revision Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Alteon® HA Femoral Stems
FDA 510(k)
FDA Class 2
·Orthopedic
World Liner
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Techmedica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933935 | CKS POROUS COATED FEMORAL COMPONENT | Oct 11, 1994 | Substantially Equivalent |
| K931929 | TECHMEDICA CONTINUUM HIP SYSTEM | Mar 29, 1994 | Substantially Equivalent |
| K926387 | TECHMEDICA STANDARD CEMENTED HIP SYSTEM | Feb 1, 1994 | Substantially Equivalent |
| K925420 | TECHMEDICA STANDARD BIPOLAR SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K923808 | MULLER STRAIGHT STEM FEMORAL PROSTHESIS | Jul 27, 1993 | Substantially Equivalent |
| K926579 | TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE | Apr 6, 1993 | Substantially Equivalent |
| K911058 | TECHMEDICA CAD/CAM CUSTOM HIP | Feb 23, 1993 | Substantially Equivalent |
| K925181 | TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP | Feb 5, 1993 | Substantially Equivalent |
| K920080 | CONTINUUM KNEE SYSTEM | Sep 1, 1992 | Substantially Equivalent for Some Indications |
| K921458 | TMP MICROPLATING SYSTEM | Jul 17, 1992 | Substantially Equivalent |