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

AUTODYNAMIC COMPRESSION HIP SCREW-PLATE

K Number: K843449 · Decision Oct 22, 1984
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
14
Review Days
47

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Basic Information

Device Name
AUTODYNAMIC COMPRESSION HIP SCREW-PLATE
K Number
K843449
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
888.3030
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Mecron Medical Products, Inc.
Date Received
September 5, 1984
Decision Date
October 22, 1984
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 Mecron Medical Products, Inc.

K Number Device Name
K861138 MASH DERMATOME
K854191 MECRON UNCEMENTED STRUCTURED STEM HIP
K844775 EFFNER-EYE CAUTERY WITH BATTERY HANDLE
K844774 EFFNER FIBER OPTIC CABLES FOR COLD LIGHT TRANSMISS
K844488 MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS
K844487 MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
K844486 MECRON MRC-HEADLESS FEMORAL COMPONENT
K844773 EFF-EFFNER BULBS
K843553 BONE PLATES
K843554 BONE SCREWS
Search all 14 clearances from Mecron Medical Products, Inc. →