FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NATURAL-KNEE(R)/APOLLO(TM) KNEE
K Number: K935523
·
Decision Jun 6, 1995
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
108
Review Days
565
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
- NATURAL-KNEE(R)/APOLLO(TM) KNEE
- K Number
- K935523
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intermedics Orthopedics
- Date Received
- November 18, 1993
- Decision Date
- June 6, 1995
- 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 Intermedics Orthopedics
| K Number | Device Name | ||
|---|---|---|---|
| K970300 | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI | Jul 3, 1997 | Substantially Equivalent |
| K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS | Apr 30, 1997 | Substantially Equivalent |
| K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM | Apr 8, 1997 | Substantially Equivalent |
| K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS | Feb 27, 1997 | Substantially Equivalent |
| K964357 | NATURAL-HIP SYSTEM COCR STEM | Jan 27, 1997 | Substantially Equivalent |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | Jan 16, 1997 | Substantially Equivalent |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | Oct 28, 1996 | Substantially Equivalent |
| K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED | Oct 15, 1996 | Substantially Equivalent |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | Oct 1, 1996 | Substantially Equivalent |
| K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | Sep 3, 1996 | Substantially Equivalent |