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

VHS SUPRACONDYLAR PLATE SYSTEM

K Number: K991806 · Decision Aug 6, 1999
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
5
Review Days
72

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Basic Information

Device Name
VHS SUPRACONDYLAR PLATE SYSTEM
K Number
K991806
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
888.3030
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Walter Abendschein, M.D.
Date Received
May 26, 1999
Decision Date
August 6, 1999
Product Code
KTT
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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Similar 510(k) Clearances

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Other Clearances by Walter Abendschein, M.D.

K Number Device Name
K011603 VHS PEDIATRIC HIP SCREW SYSTEM
K002184 COD COMPRESSION OSTEOTOMY DEVICE
K000827 UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
K964880 VARI-ANGLE HIP SCREW (VHS) SYSTEM