DTRAX Cervical Cage-B PD-31-200

GUDID 20852776006000

The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be use

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Implantable cervical facet joint distractor
Primary Device ID20852776006000
NIH Device Record Key77b230fd-78dd-437d-bef1-88fd04d44544
Commercial Distribution StatusIn Commercial Distribution
Brand NameDTRAX Cervical Cage-B
Version Model NumberPD-31-200
Catalog NumberPD-31-200
Company DUNS969820245
Company NamePROVIDENCE MEDICAL TECHNOLOGY, INC.
Device Count6
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
GS120852776006000 [Primary]
GS120852776006007 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20852776006000]

Radiation Sterilization


[20852776006000]

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 Cervical Cage-B]

10852776006000The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in va
20852776006000The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in va
20852776006069The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in va

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