Mitaka USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Mitaka USA, Inc. makes
Mitaka USA, Inc. manufactures the Point Setter, a device used for precise positioning in medical procedures, including orthopedic and spinal applications. The Point Setter is designed to assist in accurate alignment and fixation of surgical implants, ensuring proper placement during procedures.
The company’s products fall under FDA Class II regulation and are listed via the 510(k) clearance process. These devices are intended for use in the United States, where they are subject to compliance with FDA requirements for medical device authorization.
Catalogue
Mitaka Point Setter Ref K991989
Regimes: 510(k) Registry: 510(k)Point Setter Ref K984355
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Mitaka USA, Inc., initiated on 2009-02-27. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2009
- 27 Feb 2009 Z-1539-2012 Unclassified (pre-2012) Terminated Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.
Full distribution text
- 27 Feb 2009 Z-1539-2012 Unclassified (pre-2012) Terminated Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.
Frequently asked questions
How many devices does Mitaka USA, Inc. have in the registry?
The registry currently lists 2 devices for Mitaka USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mitaka USA, Inc.'s devices?
Among its 2 most recently registered devices, Mitaka USA, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Mitaka USA, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Mitaka USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mitaka USA, Inc.?
FDA recall records list 1 recall initiated by Mitaka USA, Inc., the most recent initiated on 27 Feb 2009. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Mitaka USA, Inc. in the registry?
The most recently registered devices listed for Mitaka USA, Inc. include MITAKA POINT SETTER and POINT SETTER.