FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RASPS FOR SCRAPING BONE
K Number: K771745
·
Decision Sep 28, 1977
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
8
Applicant Total
303
Review Days
13
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Basic Information
- Device Name
- RASPS FOR SCRAPING BONE
- K Number
- K771745
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- September 15, 1977
- Decision Date
- September 28, 1977
- Product Code
- HTR
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| HTR | Rasp | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTR), ordered by most recent decision date.
BIODYNAMICS SMALL JOINT BRUSH #1203
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ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202
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BIODYNAMICS FEMORAL CANAL BRUSH #1201
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RICHARDS ACETABULAR BRUSH
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THE ARTHROFILE
FDA 510(k)
FDA Class 1
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MICRO RASPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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| K032151 | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS | Sep 26, 2003 | Substantially Equivalent |
| K020541 | AGILITY ANKLE REVISION PROSTHESIS | May 20, 2002 | Substantially Equivalent |
| K011810 | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | Sep 7, 2001 | Substantially Equivalent |