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510(k) K885229

Device
MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
Applicant
ROMANO SURGICAL INSTRUMENTATION, INC.
510(k) number
K885229
Product code
HSZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-29
Date received
1988-12-09
Regulation
878.4820
Classification name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Medical specialty
General & Plastic Surgery
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JACK W ROMANO
Address
4000 Aurora Ave. N., Suite 112 Seattle WA US 98103 98103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HSZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical Systems1999-07-21
K972860CURVTEK TSR SYSTEMBiolectron, Inc.1997-10-31
K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.1997-04-29
K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.1996-01-17
K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SA1995-10-16
K944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, Inc.1995-05-11
K934336SPINALPLANESynvasive Technology, Inc.1995-03-10
K940276FILTER, DIFFUSERAnspach Mfg., Inc.1994-11-16
K942760PNEUMATIC WIRE TENSIONERSmith & Nephew Richards, Inc.1994-09-06
K941681ARTHREX CIRCULAR HARVESTING SAWArthrex, Inc.1994-08-25
K935367TAVA WIRE-DRIVERTava Surgical Instruments1994-04-21
K934431PNEUMATIC WIRE TENSIONERSmith & Nephew Richards, Inc.1994-01-27
K930784THE DE SOUTTER M193 REAMERDe Soutter Medical, Ltd.1993-10-27
K930785THE DE SOUTTER M182 DRILLDe Soutter Medical, Ltd.1993-10-27
K926547MEDNEXT 1000 BONE DISSECTING SYSTEMMednext, Inc.1993-07-22

Legacy Summary#

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FDA Review#

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