FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD
K Number: K903885
·
Decision Sep 13, 1990
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
106
Applicant Total
33
Review Days
23
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
- KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD
- K Number
- K903885
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Kinamed, Inc.
- Date Received
- August 21, 1990
- Decision Date
- September 13, 1990
- Product Code
- KWL
- 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 |
|---|---|---|---|
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWL), ordered by most recent decision date.
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
OsteoRemedies Hip Spacer System
FDA 510(k)
FDA Class 2
·Orthopedic
InterSpace GV Hip Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
FDA 510(k)
FDA Class 2
·Orthopedic
COPAL® exchange G hip spacer; COPAL® G+V
FDA 510(k)
FDA Class 2
·Orthopedic
UHR Bipolar Implants, Restoration GAP II Implants
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Kinamed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K122049 | NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM | Apr 5, 2013 | Substantially Equivalent |
| K072250 | SUPERCABLE GRIP AND PLATE SYSTEM | Nov 9, 2007 | Substantially Equivalent |
| K050897 | NAVIPRO SHOULDER SOFTWARE MODULE | May 24, 2005 | Substantially Equivalent |
| K033668 | NAVIPRO KNEE SOFTWARE MODULE | Mar 11, 2004 | Substantially Equivalent |
| K032950 | GEM INSET PATELLAR COMPONENT | Dec 19, 2003 | Substantially Equivalent |
| K030256 | ISO-ELASTIC CERCLAGE SYSTEM | Oct 21, 2003 | Substantially Equivalent |
| K020764 | NAVIPRO | Jun 3, 2002 | Substantially Equivalent |
| K013982 | KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT | May 21, 2002 | Substantially Equivalent |
| K010101 | GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM | May 17, 2001 | Substantially Equivalent |
| K003347 | ORTHOPILOT | Feb 23, 2001 | Substantially Equivalent |