FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

RD 140 SURGICAL BENDER

K Number: K870084 · Decision Jan 28, 1987
Classifications
1
FEI Numbers
226
Registration Numbers
226
Same Product Code
2
Applicant Total
9
Review Days
20

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Basic Information

Device Name
RD 140 SURGICAL BENDER
K Number
K870084
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
888.4540
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Terray Manufacturing, Inc.
Date Received
January 8, 1987
Decision Date
January 28, 1987
Product Code
HXW
Advisory Committee
Orthopedic
Review Advisory Committee
OR
Third Party
N

Classifications

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

Product Code Device Name
HXW Bender

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K870085 ANTERIOR SPINAL FIXATION PLATE
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