FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B-P HEMISPHERICAL ACETABULAR COMPONENT
K Number: K963101
·
Decision Feb 12, 1997
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
15
Review Days
187
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
- B-P HEMISPHERICAL ACETABULAR COMPONENT
- K Number
- K963101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Endotec, Inc.
- Date Received
- August 9, 1996
- Decision Date
- February 12, 1997
- 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 Endotec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081400 | FANNING-PAPPAS MODULAR KNEE BEARING | Feb 20, 2009 | Substantially Equivalent |
| K012702 | BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 | Jan 30, 2002 | Substantially Equivalent |
| K992394 | BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT | Oct 15, 1999 | Substantially Equivalent |
| K982418 | BUECHEL-PAPPAS MODULAR SALVAGE STEM | Apr 29, 1999 | Substantially Equivalent |
| K963100 | TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP | Feb 12, 1997 | Substantially Equivalent |
| K960425 | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX | Oct 3, 1996 | Substantially Equivalent |
| K960424 | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD | Aug 26, 1996 | Substantially Equivalent |
| K945254 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES | Jun 6, 1995 | Substantially Equivalent |
| K944465 | CARRIER, LIGATURE (79 GEJ) | Sep 28, 1994 | Substantially Equivalent |
| K944414 | DEKALB | Sep 27, 1994 | Substantially Equivalent |