FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INTERMEDULLARY BRUSH
K Number: K771016
·
Decision Jan 12, 1978
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
8
Applicant Total
373
Review Days
220
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Basic Information
- Device Name
- INTERMEDULLARY BRUSH
- K Number
- K771016
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Howmedica Corp.
- Date Received
- June 6, 1977
- Decision Date
- January 12, 1978
- 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
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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
Other Clearances by Howmedica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983528 | MICRO DYNAMIC MESH | Dec 23, 1998 | Substantially Equivalent |
| K983404 | TYPE 3 FEMORAL COMPONENTS | Dec 22, 1998 | Substantially Equivalent |
| K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K983419 | HOFFMANN II MIAMI POST | Nov 25, 1998 | Substantially Equivalent |
| K982958 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Nov 20, 1998 | Substantially Equivalent |
| K982873 | ZETA MULTIZONE SCN LOCKING NAIL | Oct 21, 1998 | Substantially Equivalent |
| K982531 | HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM | Oct 16, 1998 | Substantially Equivalent |