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

INTRAMEDULLARY HIP SCREW

K Number: K895241 · Decision Jan 4, 1990
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
71
Review Days
136

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Basic Information

Device Name
INTRAMEDULLARY HIP SCREW
K Number
K895241
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
888.3030
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Richards Medical Co., Inc.
Date Received
August 21, 1989
Decision Date
January 4, 1990
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

Other 510(k) clearances with the same product code (KTT), ordered by most recent decision date.

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Other Clearances by Richards Medical Co., Inc.

K Number Device Name
K896106 ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS
K900628 MODULAR HIP SYSTEM
K896580 UNI-POLAR HEAD
K884824 TRICON-M TOTAL KNEE SYSTEM
K896204 ZIRCONIA CERAMIC HEAD ADD'L SIZES
K895242 PAPPAS TRI-FLANGE VENTILATION TUBE
K893377 RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS
K885069 ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED)
K892366 POROUS GENESIS STEMMED TIBIAL COMPONENT
K890132 POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
Search all 71 clearances from Richards Medical Co., Inc. →