Fine osteotomy HA 4.5 Cortical Bone Screw - L62mm

GUDID 00688346002645

Button Head Spherical Seat HA 4.5 Cortical Self Tapping Bone Screw - L62mm

Laboratoires Bodycad Inc

Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)
Primary Device ID00688346002645
NIH Device Record Key2fa5b674-2006-4a9d-9670-6e37b79a2833
Commercial Distribution StatusIn Commercial Distribution
Brand NameFine osteotomy HA 4.5 Cortical Bone Screw - L62mm
Version Model Number037-106-062
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100688346002645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


[00688346002645]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-30
Device Publish Date2023-10-20

Devices Manufactured by Laboratoires Bodycad Inc

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00688346000108 - Fine Osteotomy implants - Distal femur2024-02-19 Distal femur, plate, screws (cortical/cancellous compression)
00688346000122 - Fine Osteotomy implants - Proximal tibia2024-02-19 Proximal tibia, plate, screws (cortical/cancellous compression)
00688346000283 - Fine Osteotomy system - Distal femur2024-02-19 Distal femur, plate, screws (cortical locking, cancellous compression), guides
00688346000290 - Fine Osteotomy system - Distal femur2024-02-19 Distal femur, plate, cancellous screws compression, guides
00688346000320 - Fine Osteotomy system - Distal femur2024-02-19 Distal femur, plate, cortical locking screws, guides
00688346000337 - Fine Osteotomy system - Distal femur2024-02-19 Distal femur, plate, screws (cortical locking, cortical compression), guides

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