FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

LINK ACETABULAR MESH

K Number: K844225 · Decision Nov 14, 1984
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
162
Applicant Total
42
Review Days
13

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Basic Information

Device Name
LINK ACETABULAR MESH
K Number
K844225
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.3300
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Waldemar Link GmbH & Co. KG
Date Received
November 1, 1984
Decision Date
November 14, 1984
Product Code
FTM
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

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

Product Code Device Name
FTM Mesh, Surgical

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K231445 LINK Embrace Shoulder System - Reverse Configuration
K222066 LINK MobileLink Acetabular Cup System
K230471 LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
K213770 SP-CL Hip Stem and LCU Hip System
K221794 Vario-Cup System
K211567 BiMobile Instruments (for BiMobile Dual Mobility System)
K220628 LINK Endo-Model EVO Knee System
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