FDA 510(k) FDA class 3 Substantially Equivalent 🇬🇧 United Kingdom

MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT

K Number: K871956 · Decision Jun 23, 1987
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
113
Applicant Total
60
Review Days
34

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Basic Information

Device Name
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
K Number
K871956
Device Class
FDA class 3
Clearance Type
Traditional
Regulation Number
888.3330
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Downs Surgical , Ltd.
Date Received
May 20, 1987
Decision Date
June 23, 1987
Product Code
KWA
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
KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

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K900611 SHEPPERD DILATATION TUBE SET (GS-501-20-H)
K900614 SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V)
K900612 SHEPPERD TREPHINE SET (GS-501-30-V)
K900610 SHEPPERD CANNULA STILLETTE & OBDURATOR SET
K900616 SHEPPERD CUTTING FORCEPS
K900609 SHEPPERD STRAIGHT AND CURVED NEEDLES
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