Fine osteotomy HA 4.5 Cortical Bone Screw - L34mm

GUDID 00688346002508

Button Head Spherical Seat HA 4.5 Cortical Self Tapping Bone Screw - L34mm

Laboratoires Bodycad Inc

Orthopaedic bone screw (non-sliding)

Primary Device ID	00688346002508
NIH Device Record Key	19de1b1a-1f79-4b7f-a5dc-3d4e95369e4e
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fine osteotomy HA 4.5 Cortical Bone Screw - L34mm
Version Model Number	037-106-034
Company DUNS	202981171
Company Name	Laboratoires Bodycad Inc
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00688346002508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K231314

FDA Product Code

HWC	Screw, Fixation, Bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

[00688346002508]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-10-30
Device Publish Date	2023-10-20

Devices Manufactured by Laboratoires Bodycad Inc

00688346000047 - Fine Osteotomy system - Proximal tibia	2024-02-19 Proximal tibia, plate, screws (compression cortical/cancellous), guides
00688346000078 - Fine Osteotomy system - Distal femur	2024-02-19 Distal femur, plate, screws (compression cortical/cancellous), guides
00688346000108 - Fine Osteotomy implants - Distal femur	2024-02-19 Distal femur, plate, screws (cortical/cancellous compression)
00688346000122 - Fine Osteotomy implants - Proximal tibia	2024-02-19 Proximal tibia, plate, screws (cortical/cancellous compression)
00688346000283 - Fine Osteotomy system - Distal femur	2024-02-19 Distal femur, plate, screws (cortical locking, cancellous compression), guides
00688346000290 - Fine Osteotomy system - Distal femur	2024-02-19 Distal femur, plate, cancellous screws compression, guides
00688346000320 - Fine Osteotomy system - Distal femur	2024-02-19 Distal femur, plate, cortical locking screws, guides
00688346000337 - Fine Osteotomy system - Distal femur	2024-02-19 Distal femur, plate, screws (cortical locking, cortical compression), guides

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