FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MITEK THRADED ANCHOR (MTA)
K Number: K945203
·
Decision Mar 6, 1995
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
31
Review Days
132
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Basic Information
- Device Name
- MITEK THRADED ANCHOR (MTA)
- K Number
- K945203
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mitek Surgical Products, Inc.
- Date Received
- October 25, 1994
- Decision Date
- March 6, 1995
- Product Code
- JDR
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
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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 |
| 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 |
| K931253 | QUICKANCHOR II | Jun 16, 1994 | Substantially Equivalent |