FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

4-BAR KNEE-SHIN SET-UP

K Number: K761313 · Decision Jan 10, 1977
Classifications
1
FEI Numbers
248
Registration Numbers
248
Same Product Code
42
Applicant Total
9
Review Days
28

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Basic Information

Device Name
4-BAR KNEE-SHIN SET-UP
K Number
K761313
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
890.5370
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Hosmer Dorrance Corp.
Date Received
December 13, 1976
Decision Date
January 10, 1977
Product Code
ION
Advisory Committee
Physical Medicine
Review Advisory Committee
PM
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
ION Exerciser, Non-Measuring

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Other Clearances by Hosmer Dorrance Corp.

K Number Device Name
K822632 ELBOW PROSTHESIS
K821704 FRACTURE BRACING
K801788 HUMEROUS FRACTURE BRACE, ULNA FRACTURE
K780891 POST-OPERATIVE HIP ORTHOSIS
K780892 FRACTURE BRACING
K780890 CAPP TERMINAL DEVICE
K761312 ORTHOTIC BRACING
K761314 FLEXION-BRAKING KNEE-SHIN ASSEMBLY