FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PSL TOTAL HIP REPLACEMENT SYSTEM
K Number: K922500
·
Decision Jan 7, 1994
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
41
Review Days
590
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
- PSL TOTAL HIP REPLACEMENT SYSTEM
- K Number
- K922500
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biopro, Inc.
- Date Received
- May 27, 1992
- Decision Date
- January 7, 1994
- 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 Biopro, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K163627 | Shotel Ankle Arthrodesis Nail System | Sep 14, 2017 | Substantially Equivalent |
| K162674 | BioPro Foot Plating Systems | Jun 16, 2017 | Substantially Equivalent |
| K132510 | BIOPRO - INFINITY PLATE ANCHOR SYSTEM | Oct 24, 2013 | Substantially Equivalent |
| K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | Jun 18, 2013 | Substantially Equivalent |
| K121973 | BIOPRO HEMI-EDGE TOE SYSTEM | Oct 30, 2012 | Substantially Equivalent |
| K100761 | BIOPRO POLAR HEAD | Dec 3, 2010 | Substantially Equivalent |
| K101030 | MODIFICATION TO HBS HEADLESS BONE SCREW | Jun 3, 2010 | Substantially Equivalent |
| K090208 | BIOPRO FEMORAL HEADS | May 22, 2009 | Substantially Equivalent |
| K083490 | BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 | Mar 18, 2009 | Substantially Equivalent |
| K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | Dec 15, 2008 | Substantially Equivalent |