FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RICHARDS ACETABULAR BRUSH
K Number: K813093
·
Decision Nov 20, 1981
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
8
Applicant Total
48
Review Days
18
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Basic Information
- Device Name
- RICHARDS ACETABULAR BRUSH
- K Number
- K813093
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Richard'S Medical Equip., Inc.
- Date Received
- November 2, 1981
- Decision Date
- November 20, 1981
- 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
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BIODYNAMICS FEMORAL CANAL BRUSH #1201
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
THE ARTHROFILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICRO RASPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INTERMEDULLARY BRUSH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Richard'S Medical Equip., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830793 | PATIENT GUIDED ELBOW & SHOULDER EXERC | Jun 16, 1983 | Substantially Equivalent |
| K823837 | RMC TOTAL KNEE SYSTEM | Mar 29, 1983 | Substantially Equivalent |
| K823726 | SPECTRON CONVERSION ENDOPROSTHESIS CUP | Mar 9, 1983 | Substantially Equivalent |
| K823724 | SPECTRON NECK REPLACEMENT PROSTHESIS | Mar 9, 1983 | Substantially Equivalent |
| K823723 | SPECTRON PROXIMAL FEMORAL PROSTHESIS | Mar 9, 1983 | Substantially Equivalent |
| K823722 | SPECTRON LONG, STRAIGHT FEMORAL PROSTHES | Mar 8, 1983 | Substantially Equivalent |
| K823727 | SPECTRON PRIMARY STEM FEMORAL PROSTHES | Mar 8, 1983 | Substantially Equivalent |
| K830153 | RICHARDS INTRA-ARTICULAR SHAVER BLADES | Feb 28, 1983 | Substantially Equivalent |
| K830154 | COLLES FRACTURE FRAME | Feb 2, 1983 | Substantially Equivalent |
| K823725 | SPECTRON PROTRUSIO CUP | Jan 21, 1983 | Substantially Equivalent |