FDA.reportPublic FDA data

510(k) K880381

Device
Telos Distal Targeting Device
Applicant
AUSTIN ASSOC.
510(k) number
K880381
Product code
HXY
Decision
Substantially Equivalent (SESE)
Decision date
1988-03-15
Date received
1988-01-27
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
ALBERT G AUSTIN
Address
1109 Sturbridge Rd. Fallston, MD US 21047 21047

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
K892904MITEK DRILL GUIDEMitek Surgical Products, Inc.1989-09-28
K880264BONE SUTURE FIXATION DEVICEOrthopedic Systems, Inc.1988-03-23
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