Fine Osteotomy implants - Distal femur 015-330-101

GUDID 00688346000108

Distal femur, plate, screws (cortical/cancellous compression)

Laboratoires Bodycad Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00688346000108
NIH Device Record Key6cac0dad-edfe-4767-b369-1e30002002e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameFine Osteotomy implants - Distal femur
Version Model Number015-330-101
Catalog Number015-330-101
Company DUNS202981171
Company NameLaboratoires Bodycad Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100688346000108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00688346000108]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-19
Device Publish Date2020-05-20

On-Brand Devices [Fine Osteotomy implants - Distal femur]

00688346002188015-330-104
00688346002164Femoral Plate, Cortical Locking Screws, Cancellous Compression Screws
00688346002157Femoral plate, Cortical Compression Screws, Cancellous Compression Screws
00688346000399Distal femur, plate, screws (cortical locking, cortical compression)
00688346000382Distal femur, plate, cortical locking screws
00688346000375Distal femur, plate, cortical compression screws
00688346000368Distal femur, plate, screws (cortical locking, cortical/ cancellous compression)
00688346000351Distal femur, plate, cancellous compression screws
00688346000344Distal femur, plate, screws (cortical locking, cancellous compression)
00688346000108Distal femur, plate, screws (cortical/cancellous compression)

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