DTRAX Cervical Cage-T PD-31-100

GUDID 10852776006017

The DTRAX Cervical Cage-T 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 ID10852776006017
NIH Device Record Key2952b274-3a55-4a98-9e88-e47fcf0a4bba
Commercial Distribution Discontinuation2019-03-28
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDTRAX Cervical Cage-T
Version Model NumberPD-31-100
Catalog NumberPD-31-100
Company DUNS969820245
Company NamePROVIDENCE MEDICAL TECHNOLOGY, INC.
Device Count1
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
GS110852776006017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10852776006017]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-03-29
Device Publish Date2015-09-03

Devices Manufactured by PROVIDENCE MEDICAL TECHNOLOGY, INC.

00852776006522 - PMT Cervical Harness2021-08-10 The PMT Cervical Visualization Harness stretches to conform to the outer shoulder while holding traction securely. It is used to
10852776006512 - CORUS Guide Tube Adapter2021-03-09 CORUS Guide Tube Adapter
00852776006386 - CAVUX™ Cervical Cage SE2020-02-24 CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX Cervical Cages are manufactu
00852776006423 - CAVUX™ Cervical Cage SB2020-02-24 CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufac
00852776006003 - CAVUX Cervical Cage-B2020-02-24 The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It
00852776006010 - CAVUX Cervical Cage-T2020-02-24 The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It
10852776006277 - CAVUX™ Cervical Cage-L 8x12x15mm 7 deg 2020-02-24 CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical sp
10852776006321 - CAVUX™ Cervical Cage-B 5mm2020-02-24 CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spin

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