FDA.reportPublic FDA data

TRIO TRAUMA

Primary DI
04546540697370
Brand
TRIO TRAUMA
Company
Stryker Corporation
Model
47113000
Catalog number
47113000
Device description
TORQUE WRENCH TARGETING DEVICE
Published
2014-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540697370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540697370045465406973704546540697370

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
149183167
Device count
1
DM exempt
false
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
false
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
07613327632811Maistro06200020000620-002-0002025-10-10
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327060027Precision Ideal Eyes05028190300502-819-0302016-09-23
07613327060072Precision Ideal Eyes05028230300502-823-0302016-09-23
07613327060102Precision Ideal Eyes05028231300502-823-1302016-09-23
07613327060119Precision Ideal Eyes05028270100502-827-0102016-09-23
07613327060126Precision Ideal Eyes05028230700502-823-0702016-09-23
07613327060140Precision Ideal Eyes05028270700502-827-0702016-09-23
07613327060157Precision Ideal Eyes05028271300502-827-1302016-09-23
07613327060164Precision Ideal Eyes05028270300502-827-0302016-09-23
07613327060232Precision Ideal Eyes05028230100502-823-0102016-09-23
07613327063875Precision Ideal Eyes, Speed-Lock05029270100502-927-0102016-09-23
07613327063882Precision Ideal Eyes, Speed-Lock05029270300502-927-0302016-09-23
07613327063899Precision Ideal Eyes, Speed-Lock05029270700502-927-0702016-09-23
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606190671PrimusSPINAL ELEMENTS, INC.NKB2026-10-26
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHMNH2026-10-26
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHMNI2026-10-26
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHNKB2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHMNH2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHMNI2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHNKB2026-10-26
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-25
00763000749903CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
00763000750510CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-10-23
03701313009632KHEIRONS.M.A.I.ONKB2026-10-23
03701313009649KHEIRONS.M.A.I.ONKB2026-10-23
03701313009656KHEIRONS.M.A.I.ONKB2026-10-23
03701313009663KHEIRONS.M.A.I.ONKB2026-10-23
03701313009670KHEIRONS.M.A.I.ONKB2026-10-23
03701313009687KHEIRONS.M.A.I.ONKB2026-10-23
03701313009694KHEIRONS.M.A.I.ONKB2026-10-23
03701313009700KHEIRONS.M.A.I.ONKB2026-10-23
03701313009717KHEIRONS.M.A.I.ONKB2026-10-23
03701313009724KHEIRONS.M.A.I.ONKB2026-10-23
03701313009731KHEIRONS.M.A.I.ONKB2026-10-23
03701313009748KHEIRONS.M.A.I.ONKB2026-10-23
03701313009755KHEIRONS.M.A.I.ONKB2026-10-23
03701313009762KHEIRONS.M.A.I.ONKB2026-10-23
03701313009779KHEIRONS.M.A.I.ONKB2026-10-23
03701313009786KHEIRONS.M.A.I.ONKB2026-10-23
03701313009793KHEIRONS.M.A.I.ONKB2026-10-23