FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIM FLARE ACETABULAR COMPONENT
K Number: K955033
·
Decision Jan 31, 1996
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
108
Review Days
90
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
- RIM FLARE ACETABULAR COMPONENT
- K Number
- K955033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intermedics Orthopedics
- Date Received
- November 2, 1995
- Decision Date
- January 31, 1996
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPH), ordered by most recent decision date.
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
FDA 510(k)
FDA Class 2
·Orthopedic
Taperloc® Complete Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
G7® Revision Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
Mpact 3D Metal Implants Extension DMLS Technology
FDA 510(k)
FDA Class 2
·Orthopedic
Velora Acetabular System
FDA 510(k)
FDA Class 2
·Orthopedic
TaperSet Hip System
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 |