Fine Osteotomy implants - Proximal tibia 015-410-102

GUDID 00688346000467

Proximal tibia, plate, screws (cortical locking, cancellous compression)

Laboratoires Bodycad Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00688346000467
NIH Device Record Keyf6e803f5-1e81-40b9-a224-c870410ca1ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameFine Osteotomy implants - Proximal tibia
Version Model Number015-410-102
Catalog Number015-410-102
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100688346000467 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00688346000467]

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 - Proximal tibia]

00688346002331Tibial plate, cortical locking screws, cancellous compressionscrews
00688346002324Tibial plate, Cortical compression screws, Cancellous compression screws
00688346002386Tibial plate, cortical locking screws , cortical compression screws
00688346002379Tibial plate, cortical locking screws
00688346002362Tibial plate, cortical compression screws
00688346002355Tibial plate, cortical locking screws, cortical compression screws, cancellous compression sc
00688346002348Tibial plate, cancellous compression screws
00688346000511Proximal tibia, plate, screws (cortical locking/compression)
00688346000504Proximal tibia, plate, cortical locking screws
00688346000498Proximal tibia, plate, cortical compression screws
00688346000481Proximal tibia, plate, screws (cortical locking/compression, cancellous compression)
00688346000474Proximal tibia, plate, cancellous compression screws
00688346000467Proximal tibia, plate, screws (cortical locking, cancellous compression)
00688346000122Proximal tibia, plate, screws (cortical/cancellous compression)

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