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510(k) K892904

Device
MITEK DRILL GUIDE
Applicant
MITEK SURGICAL PRODUCTS, INC.
510(k) number
K892904
Product code
HXY  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-28
Date received
1989-04-20
Regulation
888.4540
Classification name
Brace, Drill
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT P ZOLETTI
Address
990 Washington St. Dedham MA US 02026 02026

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923776BENDEREV DRILL GUIDENeimark Labs, Inc.1992-11-06
K880264BONE SUTURE FIXATION DEVICEOrthopedic Systems, Inc.1988-03-23
K880381TELOS DISTAL TARGETING DEVICEAustin Assoc.1988-03-15
K880046HASTING FINGER FIXATOR INSTRUMENTSBuckman Co., Inc.1988-02-16
K831043ANDREWS REMOTE CHUCK DRILLOrthopedic Systems, Inc.1983-04-28
K770204CEMENT EXTRACTOR DRILLDepuy, Inc.1977-02-08

Legacy Summary#

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FDA Review#

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