FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATELLAR FAT PAD RETRACTOR
K Number: K831248
·
Decision Jun 24, 1983
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
31
Review Days
67
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Basic Information
- Device Name
- PATELLAR FAT PAD RETRACTOR
- K Number
- K831248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Techmedica, Inc.
- Date Received
- April 18, 1983
- Decision Date
- June 24, 1983
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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|---|---|---|---|
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| K923808 | MULLER STRAIGHT STEM FEMORAL PROSTHESIS | Jul 27, 1993 | Substantially Equivalent |
| K926579 | TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE | Apr 6, 1993 | Substantially Equivalent |
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| K920080 | CONTINUUM KNEE SYSTEM | Sep 1, 1992 | Substantially Equivalent for Some Indications |