Mitek Worldwide
Norwood, MA, US
Mitek Worldwide appears in FDA device records in Norwood, MA. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Mitek Worldwide between 2002 and 2004. The busiest year on record is 2003, with 6. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 3 |
| 2003 | 6 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K032717 | BIOCRYL RAPIDE INTERFERENCE SCREW | HWC | Substantially Equivalent | |
| K032167 | BIO-INTRAFIX TIBIAL SCREW AND SHEATH | HWC | Substantially Equivalent | |
| K032078 | MITEK MICRO QUICKANCHOR | NOV | Substantially Equivalent | |
| K030995 | MINILOK QUICKANCHOR PLUS | HWC | Substantially Equivalent | |
| K031519 | CUFFLOK ANCHOR | MAI | Substantially Equivalent | |
| K031406 | EXOJET TISSUE MANAGEMENT SYSTEM | HRX | Substantially Equivalent | |
| K024115 | MICROFIX QUICKANCHOR PLUS | HWC | Substantially Equivalent | |
| K023388 | MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM | JDR | Substantially Equivalent | |
| K021953 | MITEK PDS/PGA STAPLE | JDR | Substantially Equivalent | |
| K021883 | BIOFASTIN RC THREADED SUTURE ANCHOR | HWC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1005-03 | Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420 | Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm | Terminated | ||
| Z-1004-03 | Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325 | Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm | Terminated | ||
| Z-0699-03 | Mitek Profile 8 x 20 mm Cannulated Interference Screw Round Head Product Reference No.: 230420 | Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm | Terminated | ||
| Z-0698-03 | Mitek Profile 7 x 25 mm Cannulated Interference Screw Round Head Product Reference No.: 230325 | Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 25 mm | Terminated | ||
| Z-0697-03 | Mitek M. Kurosaka Advantage 9 X 30 mm Cannulated Fixation Screw Product Reference No.: 230120 | Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm | Terminated | ||
| Z-0696-03 | Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw Product Reference No.: 230030 | Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm. | Terminated |
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 Worldwide 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 Worldwide. 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