Mitaka USA, Inc.

Wheat Ridge, CO, US

MITAKA USA, INC. appears in FDA device records in Wheat Ridge, CO. FDA records list 2 510(k) clearances between 1999-04-01 and 1999-08-27, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Mitaka USA, Inc. in 1999.

Clearances by year, as a table

510(k) clearance decisions for Mitaka USA, Inc., by decision year
Year	Clearances
1999	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K991989	MITAKA POINT SETTER	GWG	Substantially Equivalent	1999-08-27
K984355	POINT SETTER	GCJ	Substantially Equivalent	1999-04-01

Registered establishments

FDA registered establishments for Mitaka USA, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1724672	3002996788	MITAKA USA, INC.	11907 W 48th Ave Unit A, Wheat Ridge, CO 80033 US	2026	No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1539-2012	Mitaka Point Setter, holding system for surgical instruments. Holding surgical instruments during operating procedures.	Use of a potentially weaker spring in the device than required to meet specifications to hold the Point Setter ARM in place during surgery.		2009-02-27	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain