FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
TOWNLEY COX COMB ACETABULAR COMPONENT
K Number: K882869
·
Decision Oct 14, 1988
Classifications
1
FEI Numbers
227
Registration Numbers
227
Same Product Code
562
Applicant Total
41
Review Days
95
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
- TOWNLEY COX COMB ACETABULAR COMPONENT
- K Number
- K882869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3350
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Biopro, Inc.
- Date Received
- July 11, 1988
- Decision Date
- October 14, 1988
- Product Code
- JDI
- 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDI), ordered by most recent decision date.
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
FDA 510(k)
FDA Class 2
·Orthopedic
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
FDA 510(k)
FDA Class 2
·Orthopedic
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker Orthopaedics Hip Systems Labeling Update
FDA 510(k)
FDA Class 2
·Orthopedic
Global Modular Replacement 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 |