Mitek Surgical Products, Inc.
Dedham, MA, US
Mitek Surgical Products, Inc. appears in FDA device records in Dedham, MA. FDA records list 31 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Mitek Surgical Products, Inc. between 1989 and 1996. The busiest year on record is 1992, with 7. The most recent is 1996, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 7 |
| 1993 | 3 |
| 1994 | 5 |
| 1995 | 7 |
| 1996 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K953560 | MITEK THREADED ANCHOR (FASTIN) | MBI | Substantially Equivalent for Some Indications | |
| K953877 | MITEK GII ANCHOR | MBI | Substantially Equivalent | |
| K936311 | MITEK MINI ANCHOR | MNV | Substantially Equivalent for Some Indications | |
| K941599 | MITEK ABSORBABLE ANCHOR | MNV | Substantially Equivalent for Some Indications | |
| K944051 | ABSORBALBE ANCHOR | MNV | Substantially Equivalent | |
| K950070 | MITEK TOGGLE ANCHOR(TM) | JDR | Substantially Equivalent | |
| K944936 | MITEK G III ANCHOR, MITEK LS ANCHOR | JDR | Substantially Equivalent | |
| K945203 | MITEK THRADED ANCHOR (MTA) | JDR | Substantially Equivalent | |
| K934366 | MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER | HWC | Substantially Equivalent for Some Indications | |
| K931782 | MITEK GIII ANCHOR | JDR | Substantially Equivalent for Some Indications | |
| K931253 | QUICKANCHOR II | JDR | Substantially Equivalent | |
| K935225 | MITEK MODULAR DRILL BIT | GFG | Substantially Equivalent | |
| K930892 | MITEK MINI ANCHOR, MODIFICATION | JDR | Substantially Equivalent | |
| K930893 | MITEK SUPER QUICKANCHOR, MODIFICATION | JDR | Substantially Equivalent | |
| K930675 | MITEK CONE WASHER | KGS | Substantially Equivalent | |
| K926270 | MITEK LIGAMENT ANCHOR | JDR | Substantially Equivalent | |
| K923161 | BRAIDED POLYESTER SUTURE MATERIAL | GAS | Substantially Equivalent | |
| K924665 | QUICKANCHOR | JDR | Substantially Equivalent | |
| K915889 | MITEK BONE ANCHOR, MODIFICATION | JDR | Substantially Equivalent | |
| K921873 | QUICKANCHOR, MODIFICATION | JDR | Substantially Equivalent | |
| K920213 | MITEK ANCHOR, MITEK ANCHOR II | JDR | Substantially Equivalent | |
| K915089 | MITEK QUICKANCHOR(TM), MODIFICATION | GAS | Substantially Equivalent | |
| K915081 | MITEK SNAP PAK(TM), MODIFICATION | GAS | Substantially Equivalent | |
| K905112 | SNAP-PAK (TM) | JDR | Substantially Equivalent | |
| K904436 | QUICKANCHOR (TM) | GAS | Substantially Equivalent | |
| K902751 | MITEK ANCHOR II | JDR | Substantially Equivalent | |
| K897155 | MITEK ANCHOR(TM) | JDR | Substantially Equivalent | |
| K892903 | MITEK ANCHOR DRILL | HTW | Substantially Equivalent | |
| K892904 | MITEK DRILL GUIDE | HXY | Substantially Equivalent | |
| K892126 | MITEK ANCHOR | JDR | Substantially Equivalent | |
| K893886 | MITEK STERILIZATION TRAY | FLE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain