Mitek Products
Westwood, MA, US
Mitek Products appears in FDA device records in Westwood, MA. FDA records list 30 510(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
- 30
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 30 510(k) clearances for Mitek Products between 1996 and 2002. The busiest year on record is 1999, with 8. The most recent is 2002, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 3 |
| 1997 | 3 |
| 1998 | 7 |
| 1999 | 8 |
| 2000 | 4 |
| 2001 | 3 |
| 2002 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K013572 | MITEK BIOCRYL INTERFERENCE SCREWS | HWC | Substantially Equivalent | |
| K013781 | RIDIDFIX 2.7MM BTB CROSS PIN KIT | HTY | Substantially Equivalent | |
| K002639 | BIOKNOTLESS ANCHOR | GAM | Substantially Equivalent | |
| K010633 | RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM | HWC | Substantially Equivalent | |
| K002406 | MITEK 2GII MENISCAL REPAIR SYSTEM | MAI | Substantially Equivalent | |
| K003076 | MITEK CUFFTACK | MAI | Substantially Equivalent | |
| K002422 | VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM | GEI | Substantially Equivalent | |
| K002402 | VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM | HRX | Substantially Equivalent | |
| K000936 | VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM | GEI | Substantially Equivalent | |
| K993575 | RESOLVE QUICKANCHOR | DZL | Substantially Equivalent | |
| K993327 | TALON ANCHOR SNAP-PAK | DZL | Substantially Equivalent | |
| K993261 | TALON ANCHOR SNAP-PAK | MBI | Substantially Equivalent | |
| K992623 | MITEK MINI ANCHOR | DZL | Substantially Equivalent | |
| K992876 | VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM | HRX | Substantially Equivalent | |
| K992611 | MITEK ROTATOR CUFF QUICKANCHOR PLUS | HWC | Substantially Equivalent | |
| K992487 | MITEK MINI QUICKANCHOR PLUS | HWC | Substantially Equivalent | |
| K992406 | VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM | GEI | Substantially Equivalent | |
| K983818 | MITEK FASTIN RC ANCHOR | MBI | Substantially Equivalent | |
| K982420 | MITEK MICRO ANCHOR | JDR | Substantially Equivalent | |
| K974341 | MITEK BTB ABSORBABLE (PLA) CROSS PIN | HTY | Substantially Equivalent | |
| K974291 | MITEK BTB ABSORBABLE (PLA) CROSS PIN | HTY | Substantially Equivalent | |
| K974345 | MITEK KNOTLESS ANCHOR | MBI | Substantially Equivalent | |
| K970119 | MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX | MBI | Substantially Equivalent | |
| K974022 | VAPR | GEI | Substantially Equivalent | |
| K973009 | MITEK NON ABSORBABLE POLYPROPYLENE H FIX | MBI | Substantially Equivalent | |
| K970360 | MITEK SUTURE RETROGRADER | HWQ | Substantially Equivalent | |
| K964013 | MITEK ABSORBABLE TOGGLE ANCHOR | MAI | Substantially Equivalent | |
| K962511 | MITEK MICRO ANCHOR | MBI | Substantially Equivalent | |
| K961094 | MITEK THREADED ANCHOR (MODIFICATION) | MBI | Substantially Equivalent | |
| K962793 | MITEK MICRO ANCHOR | JDR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HRXArthroscope
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HWQPasser
- HTYPin, Fixation, Smooth
- HWCScrew, Fixation, Bone
- DZLScrew, Fixation, Intraosseous
- JDRStaple, Fixation, Bone
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Mitek Products edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Mitek Products. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain