FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A
K Number: K982248
·
Decision Aug 31, 1998
Classifications
1
FEI Numbers
271
Registration Numbers
271
Same Product Code
551
Applicant Total
36
Review Days
66
Basic Information
- Device Name
- HOWMEDICA ASYMMETRIC STEM VITALOCK CLUSTER & SPIKED SHELLS, AND ACETABULAR SHELLS WITH MESH INGROWTH SURFACE WITH PERI-A
- K Number
- K982248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HOWMEDICA, INC.
- Date Received
- June 26, 1998
- Decision Date
- August 31, 1998
- 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 |
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