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510(k) K882078

Device
SPINAL SURGERY FRAME
Applicant
KARLIN TECHNOLOGY, INC.
510(k) number
K882078
Product code
FWZ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-16
Date received
1988-05-17
Regulation
878.4950
Classification name
Operating Room Accessories Table Tray
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARK WEIDHAAS
Address
330 Washington St. Suite 314 Marina Del Rey CA US 90292 90292

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FWZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960019RETRACTOR ARM CLAMPBiopsys Medical, Inc.1996-02-09
K945415'LIL MAC ACCESSORY CLAMP(TM)D.L. Nelson and Assoc., Inc.1994-11-22
K944779CARBON LIGHTS HAND SURGERY TABLEAllen Medical Systems, Inc.1994-10-14
K935381KAPS POSITIONING ARMAndronic Devices, Ltd.1994-04-15
K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)Whitmore Ent., Inc.1993-07-30
K926225SPONGE COUNTERAmerican Medical Manufacturer, Inc.1993-03-05
K925035MIDKIFF GEOSTATIC CLAMPD.L. Nelson and Assoc., Inc.1993-02-18
K905565LATERAL BUTTRESS SUPPORTMcconnell Orthopedic1991-02-21
K905564PREP AND OPERATING STANDMcconnell Orthopedic1991-02-21
K910031PARK CITY SHOULDER POSITIONEROrthopedic Systems, Inc.1991-01-24
K904826TKO TELESCOPING LITHOTOMY STIRRUPD.L. Nelson and Assoc., Inc.1990-10-31
K897028LINCOLN MILLS FOOT AND LEG HOLDERLincoln Mills, Inc.1990-01-12
K893969DECUBITUS CARE PADGulftrade Exim, Inc.1989-07-14
K890501SECOND ASSISTANT3M Company1989-02-10
K885215LINCOLN MILLS HIP HOLDERLincoln Mills, Inc.1989-01-13

Legacy Summary#

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FDA Review#

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