FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIODYNAMICS SMALL JOINT BRUSH #1203
K Number: K870333
·
Decision Feb 13, 1987
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
8
Applicant Total
30
Review Days
16
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Basic Information
- Device Name
- BIODYNAMICS SMALL JOINT BRUSH #1203
- K Number
- K870333
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Biodynamic Technologies, Inc.
- Date Received
- January 28, 1987
- Decision Date
- February 13, 1987
- 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.
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
RICHARDS ACETABULAR BRUSH
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 Biodynamic Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990436 | ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM | Mar 31, 1999 | Substantially Equivalent |
| K990481 | ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM | Mar 17, 1999 | Substantially Equivalent |
| K990513 | ULTIMAX CORTICAL BONE SCREWS | Mar 17, 1999 | Substantially Equivalent |
| K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Jun 1, 1998 | Substantially Equivalent |
| K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM | Apr 3, 1998 | Substantially Equivalent |
| K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS | Mar 12, 1998 | Substantially Equivalent for Some Indications |
| K972403 | BTI CORTICAL BONE SCREWS | Aug 29, 1997 | Substantially Equivalent |
| K970897 | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Apr 21, 1997 | Substantially Equivalent |
| K962706 | EZ-FIX CANNULATED SCREW SYSTEM | Nov 13, 1996 | Substantially Equivalent |
| K962987 | EZ-FIX SMALL CANNULATED SCREW SYSTEM | Nov 4, 1996 | Substantially Equivalent |