FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED
K Number: K934729
·
Decision Jul 22, 1994
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
9
Review Days
296
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
- UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED
- K Number
- K934729
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Implantology Corp.
- Date Received
- September 29, 1993
- Decision Date
- July 22, 1994
- Product Code
- MEH
- 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 |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MEH), ordered by most recent decision date.
Allure Hip Stem and Intramedullary Plugs
FDA 510(k)
FDA Class 2
·Orthopedic
Mfinity Femoral System
FDA 510(k)
FDA Class 2
·Orthopedic
Trivicta® Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Resolve Modular Revision Hip Stem
FDA 510(k)
FDA Class 2
·Orthopedic
Alteon® HA Femoral Stems
FDA 510(k)
FDA Class 2
·Orthopedic
World Liner
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Implantology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K915529 | FPC/SFPC/RFPC ACETABULAR COMPONENT | Jul 13, 1993 | Substantially Equivalent |
| K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT | Jun 29, 1993 | Substantially Equivalent |
| K915527 | CPS ACETABULAR COMPONENT | Jun 24, 1993 | Substantially Equivalent |
| K915385 | PPC HIP STEM COMPONENT | May 17, 1993 | Substantially Equivalent for Some Indications |
| K924099 | UFC HIP STEM COMPONENT | Apr 30, 1993 | Substantially Equivalent |
| K915391 | FPC HIP STEM COMPONENT | Apr 30, 1993 | Substantially Equivalent |
| K915798 | PSK POSTERIOR STABILIZED TOATAL KNEE | Mar 4, 1993 | Substantially Equivalent |
| K915584 | CRK CONDYLAR RESURFACING TOTAL KNEE | Feb 12, 1993 | Substantially Equivalent |