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510(k) K883576

Device
HORIZON ORTHOPEDIC PIN PROTECTOR
Applicant
HORIZON MEDICAL, INC.
510(k) number
K883576
Product code
LYT  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-30
Date received
1988-08-22
Regulation
888.3030
Classification name
Fixation Accessory
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KENNETH R BLAKE
Address
324 State St. St. Paul MN US 55107 55107

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LYT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040363CERAMIC TIPPED SKULL PINThe Jerome Group, Inc.2004-04-12
K983685BONE BANDChapel and Assoc.1998-12-04
K980594OSTEONICS FX-CABLELOK GRIP COMPONENTSOsteonics Corp.1998-05-05
K914812K-CAP-E, STERILEWestcon Orthopedics, Inc.1992-01-09
K912762K-CAP-I, STERILEWestcon Orthopedics, Inc.1991-07-18
K902053K-CAP-I ORTHOPEDIC FIXATION WIRE CAPWestcon Orthopedics, Inc.1990-09-14
K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSMicro-Aire Surgical Instruments, Inc.1990-09-14
K831072JURGAN PIN BALLJurgan Development & Mfg., Ltd.1983-06-08

Legacy Summary#

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FDA Review#

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