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510(k) K800143

Device
DYNAMIC EXTENSOR SPLINT
Applicant
BIOMET, INC.
510(k) number
K800143
Product code
ILH  
Decision
Substantially Equivalent (SESE)
Decision date
1980-02-19
Date received
1980-01-21
Regulation
890.3475
Classification name
Splint, Hand, And Components
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ILH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K832144SPLINT WOODVermont Wood Industries, Inc.1983-08-01
K831548SPLINTSFred Sammons, Inc.1983-06-27
K823647FINGER EXTENSION SPLINTFred Sammons, Inc.1983-01-21
K823644FINGER FLEXION SPLINTFred Sammons, Inc.1983-01-21
K823666UNIVERSAL WRIST SPLINT & FOREARM SPLINTWarm & Form, Orthopedic Materials1982-12-30
K823601WRIST SUPPORTFred Sammons, Inc.1982-12-22
K823393STAX FINGER SPLINTSOrthopedic Systems, Inc.1982-12-03
K823165WRIST SPLING & FOREARM SPLINTWarm & Form, Orthopedic Materials1982-11-16
K822651TOTAL FINGER FLEXION SPLINTAlimed, Inc.1982-09-17
K821637WIRE-FOAM MP FLEXION SPRINGFred Sammons, Inc.1982-06-11
K821635SOFT ULNAR DEVIATION SPLINTSFred Sammons, Inc.1982-06-11
K820826STAX FINGER SPLINTConco Medical Co.1982-04-08
K820382FROG SPLINTConco Medical Co.1982-03-01
K820381FINGER PROTECTORConco Medical Co.1982-03-01
K820380CURVED FINGER SPLINTConco Medical Co.1982-03-01

Legacy Summary#

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FDA Review#

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