Fine Osteotomy implants - Distal femur 015-330-102

GUDID 00688346002164

Femoral Plate, Cortical Locking Screws, Cancellous Compression Screws

Laboratoires Bodycad Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00688346002164
NIH Device Record Keydf9197da-2c80-4edf-b99a-481c16ea2d00
Commercial Distribution StatusIn Commercial Distribution
Brand NameFine Osteotomy implants - Distal femur
Version Model Number015-330-102
Catalog Number015-330-102
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100688346002164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSRUnit, Traction, Hip, Non-Powered, Non-Penetrating

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


[00688346002164]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-07
Device Publish Date2021-11-29

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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