Company ยท US
Mitek Products
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2002. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 |
| HWC | Screw, Fixation, Bone | 4 |
| DZL | Screw, Fixation, Intraosseous | 3 |
| HTY | Pin, Fixation, Smooth | 3 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 3 |
| HRX | Arthroscope | 2 |
| JDR | Staple, Fixation, Bone | 2 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 1 |
| HWQ | Passer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2002 | K013572 | MITEK BIOCRYL INTERFERENCE SCREWS Mitek Products | HWC |
| Feb 6, 2002 | K013781 | RIDIDFIX 2.7MM BTB CROSS PIN KIT Mitek Products | HTY |
| May 11, 2001 | K002639 | BIOKNOTLESS ANCHOR Mitek Products | GAM |
| May 9, 2001 | K010633 | RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM Mitek Products | HWC |
| Feb 15, 2001 | K002406 | MITEK 2GII MENISCAL REPAIR SYSTEM Mitek Products | MAI |
| Oct 27, 2000 | K003076 | MITEK CUFFTACK Mitek Products | MAI |
| Aug 31, 2000 | K002422 | VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM Mitek Products | GEI |
| Aug 31, 2000 | K002402 | VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM Mitek Products | HRX |
| Apr 19, 2000 | K000936 | VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM Mitek Products | GEI |
| Dec 29, 1999 | K993575 | RESOLVE QUICKANCHOR Mitek Products | DZL |
| Dec 16, 1999 | K993327 | TALON ANCHOR SNAP-PAK Mitek Products | DZL |
| Dec 2, 1999 | K993261 | TALON ANCHOR SNAP-PAK Mitek Products | MBI |
| Nov 2, 1999 | K992623 | MITEK MINI ANCHOR Mitek Products | DZL |
| Sep 24, 1999 | K992876 | VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM Mitek Products | HRX |
| Sep 22, 1999 | K992611 | MITEK ROTATOR CUFF QUICKANCHOR PLUS Mitek Products | HWC |
| Sep 21, 1999 | K992487 | MITEK MINI QUICKANCHOR PLUS Mitek Products | HWC |
| Aug 6, 1999 | K992406 | VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM Mitek Products | GEI |
| Nov 23, 1998 | K983818 | MITEK FASTIN RC ANCHOR Mitek Products | MBI |
| Aug 24, 1998 | K982420 | MITEK MICRO ANCHOR Mitek Products | JDR |
| Apr 16, 1998 | K974341 | MITEK BTB ABSORBABLE (PLA) CROSS PIN Mitek Products | HTY |
| Mar 5, 1998 | K974291 | MITEK BTB ABSORBABLE (PLA) CROSS PIN Mitek Products | HTY |
| Feb 13, 1998 | K974345 | MITEK KNOTLESS ANCHOR Mitek Products | MBI |
| Jan 30, 1998 | K970119 | MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX Mitek Products | MBI |
| Jan 12, 1998 | K974022 | VAPR Mitek Products | GEI |
| Nov 10, 1997 | K973009 | MITEK NON ABSORBABLE POLYPROPYLENE H FIX Mitek Products | MBI |
| Mar 10, 1997 | K970360 | MITEK SUTURE RETROGRADER Mitek Products | HWQ |
| Feb 24, 1997 | K964013 | MITEK ABSORBABLE TOGGLE ANCHOR Mitek Products | MAI |
| Nov 6, 1996 | K962511 | MITEK MICRO ANCHOR Mitek Products | MBI |
| Oct 3, 1996 | K961094 | MITEK THREADED ANCHOR (MODIFICATION) Mitek Products | MBI |
| Oct 1, 1996 | K962793 | MITEK MICRO ANCHOR Mitek Products | JDR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||