DTRAX Bone Screw PD-32-301

GUDID 20852776006024

The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture rep

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Implantable cervical facet joint distractor
Primary Device ID20852776006024
NIH Device Record Key2e336266-a8ff-4d76-9ca0-f4ae8d9e1950
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTRAX Bone Screw
Version Model NumberPD-32-301
Catalog NumberPD-32-301
Company DUNS969820245
Company NamePROVIDENCE MEDICAL TECHNOLOGY, INC.
Device Count30
DM Exempttrue
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 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
GS110852776006021 [Unit of Use]
GS120852776006024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20852776006024]

Radiation Sterilization


[20852776006024]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-09-15

On-Brand Devices [DTRAX Bone Screw]

10852776006024The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruct
20852776006024The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruct
20852776006021The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruct

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