Fine Osteotomy system - Distal femur 015-330-003

GUDID 00688346000290

Distal femur, plate, cancellous screws compression, guides

Laboratoires Bodycad Inc

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00688346000290
NIH Device Record Keyc8f475ae-7368-4919-b793-deb7caa6b568
Commercial Distribution StatusIn Commercial Distribution
Brand NameFine Osteotomy system - Distal femur
Version Model Number015-330-003
Catalog Number015-330-003
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
GS100688346000290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00688346000290]

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 system - Distal femur]

00688346002126Femoral Plate, Cortical Compression Screws and Disposable Instrumentation
00688346002119Femoral Plate, Cortical Locking Screws, Cortical Compression Screws, Cancellous Compression Scre
00688346002102Femoral Plate, Cancellous Compression Screws and Disposable Instrumentation
00688346002096Femoral Plate, Cortical Locking Screws, Cancellous Compression Screws and Disposable Instrumenta
00688346002089Femoral Plate, Cortical Compression Screws, Cancellous Compression Screws and Disposable Instrum
00688346000313Distal femur, plate, cortical screws compression, guides
00688346000306Distal femur, plate, screws (cancellous compression, cortical compression, cortical locking), gu
00688346002218Distal femur, plate, screws (cortical locking, cortical compression)
00688346002201Femoral plate, cortical locking screws
00688346002195Femoral plate, cortical compression screws
00688346002140Femoral plate , Cortical Locking Screws, Cortical Compression Screws and disposable instrument
00688346002133Femoral plate, cortical locking screws and disposable instrument
00688346000337Distal femur, plate, screws (cortical locking, cortical compression), guides
00688346000320Distal femur, plate, cortical locking screws, guides
00688346000290Distal femur, plate, cancellous screws compression, guides
00688346000283Distal femur, plate, screws (cortical locking, cancellous compression), guides
00688346000078Distal femur, plate, screws (compression cortical/cancellous), guides

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