FDA.reportPublic FDA data

DTRAX Bone Screw

Primary DI
20852776006024
Brand
DTRAX Bone Screw
Company
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Model
PD-32-301
Catalog number
PD-32-301
Device description
The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture rep
Published
2015-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121713000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121713000PMT BONE SCREWSProvidence Medical Technology, Inc.2012-09-27HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20852776006024PrimaryGS10
10852776006021Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085277600602420852776006024
1085277600602110852776006021

GMDN Terms#

Term, Definition table
TermDefinition
Implantable cervical facet joint distractorA sterile wedge-shaped device intended to be inserted within a cervical facet joint (spinal joint), i.e., intra-facet, for joint distraction; the distraction is intended to facilitate nerve root decompression and stabilization of the spine in the treatment of various spinal conditions. It is typically fenestrated or barbed and may incorporate a screw to expand to shape and/or to provide fixation within the joint and cervical spine stabilization. It typically includes single-use instruments (e.g., chisels, rasps) for implantation.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
969820245
Device count
30
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852776006690CORUS NAVIGATION ACCESS SYSTEM-GLX DX-01-1802025-11-03
00852776006478CORUS-LX Implant, 4mmDX-50-4072025-08-13
00852776006539CORUS-LX Implant, 5mmDX-50-4082025-08-13
00852776006546CORUS-LX LevelOne, 4mmDX-50-4092025-08-13
00852776006577CAVUX Cage-LX, 5mmPD-31-2062025-07-08
00852776006010CAVUX Cervical Cage-TPD-31-100PD-31-1002015-09-02
00852776006270CAVUX™ Cervical Cage-L 8x12x15mm 7 deg PD-31-602PD-31-6022016-10-14
00852776006324CAVUX™ Cervical Cage-B 5mmPD-31-2012016-09-26
00852776006430CORUS™ Spinal SystemDX-22-1002019-07-23
00852776006454CORUS™ Allograft Delivery Instrument PD-10-4002019-07-24
00852776006386CAVUX™ Cervical Cage SEPD-31-220 2019-07-23
00852776006423CAVUX™ Cervical Cage SBPD-31-202 2019-07-23
00852776006003CAVUX Cervical Cage-BPD-31-200PD-31-2002015-09-02
00852776006089DTRAX® Spinal SystemDX-22-100DX-22-1002017-06-27
00852776006508CORUS Spinal System-XDX-22-300DX-22-3002020-06-12
00852776006492CAVUX Cervical Cage-XPD-31-203PD-31-2032020-06-12
00852776006256CAVUX™ Cervical Cage-L 6x12x15mm 7 deg PD-31-600PD-31-6002016-10-14
00852776006263CAVUX™ Cervical Cage-L 7x12x15mm 7 degPD-31-601PD-31-6012016-10-14
00852776006287CAVUX™ Cervical Cage-L 9x12x15 mm 7 deg PD-31-603PD-31-6032016-10-14
00852776006294CAVUX™ Cervical Cage-L 10x12x15mm 7 deg PD-31-604PD-31-6042016-10-14

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Primary DI, Brand, Company table
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00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
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