FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MITEK MODULAR DRILL BIT
K Number: K935225
·
Decision Apr 7, 1994
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
2
Applicant Total
31
Review Days
157
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Basic Information
- Device Name
- MITEK MODULAR DRILL BIT
- K Number
- K935225
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mitek Surgical Products, Inc.
- Date Received
- November 1, 1993
- Decision Date
- April 7, 1994
- Product Code
- GFG
- 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 |
|---|---|---|---|
| GFG | Bit, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GFG), ordered by most recent decision date.
MICRO DRILLS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KEY DRILL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Mitek Surgical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953560 | MITEK THREADED ANCHOR (FASTIN) | Jan 31, 1996 | Substantially Equivalent for Some Indications |
| K953877 | MITEK GII ANCHOR | Dec 29, 1995 | Substantially Equivalent |
| K936311 | MITEK MINI ANCHOR | Oct 31, 1995 | Substantially Equivalent for Some Indications |
| K941599 | MITEK ABSORBABLE ANCHOR | Oct 24, 1995 | Substantially Equivalent for Some Indications |
| K944051 | ABSORBALBE ANCHOR | Aug 2, 1995 | Substantially Equivalent |
| K950070 | MITEK TOGGLE ANCHOR(TM) | May 22, 1995 | Substantially Equivalent |
| K944936 | MITEK G III ANCHOR, MITEK LS ANCHOR | Mar 24, 1995 | Substantially Equivalent |
| K945203 | MITEK THRADED ANCHOR (MTA) | Mar 6, 1995 | Substantially Equivalent |
| K934366 | MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER | Oct 7, 1994 | Substantially Equivalent for Some Indications |
| K931782 | MITEK GIII ANCHOR | Jul 22, 1994 | Substantially Equivalent for Some Indications |