FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143
K Number: K960363
·
Decision Feb 18, 1997
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
2
Applicant Total
441
Review Days
390
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Basic Information
- Device Name
- BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143
- K Number
- K960363
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet, Inc.
- Date Received
- January 25, 1996
- Decision Date
- February 18, 1997
- Product Code
- MJT
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MJT | Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented | FDA class 3 | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MJT), ordered by most recent decision date.
OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
FDA 510(k)
FDA Class 3
·Unknown
BUECHEL-PAPPAS MODULAR SALVAGE STEM
FDA 510(k)
FDA Class 3
·Unknown
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