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510(k) K863147

Device
GLENOID DRILL
Applicant
BOWEN & COMPANY, INC.
510(k) number
K863147
Product code
HTW  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-05
Date received
1986-08-15
Regulation
888.4540
Classification name
Bit, Drill
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CARL APPLE
Address
1800 Chapman Ave. Rockville MD US 20852 20852

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HTW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151661Renovo Life Hard Carbon Coated Drill BitRenovo Life, LLC2016-01-15
K942906AGEE-WRISTJACK PRE-DRILL KITHand Biomechanics Lab, Inc.1994-12-22
K930339REAMER BITNeoligaments, Ltd.1993-08-06
K915692CANNULATED DRILL BITW. L. Gore & Associates, Inc.1992-01-16
K892903MITEK ANCHOR DRILLMitek Surgical Products, Inc.1989-10-06
K870217FEMORAL CEMENT REMOVAL INSTRUMENTSKenneth J. Hoek, M.D., Inc.1987-02-06
K841629DRILL BITPlastafil, Inc.1984-08-27
K834229BONE PLUGGING TOOLStandard Surgical1984-01-10
K831712SURGICAL DRILL BITSMedical Specialists IN Packaging1983-07-07
K820226UNIVERSALL DRILL GUIDEOrtho Pared Instruments, Inc.1982-02-04

Legacy Summary#

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FDA Review#

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