FDA.reportPublic FDA data

Tecomet

Primary DI
00841435105294
Brand
Tecomet
Company
TECOMET INC.
Model
SC324022-E
Device description
"TORQUE-LIMITING, AXIAL MINI 1/4"" SQUARE QUICK LOCK 22LBS.-IN. GRAY ORTHO-GRIP™"
Published
2020-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841435105294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841435105294008414351052948414351052940841435105294

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
078749695
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818069012915Tecomet3741062023-07-23
00841435109810TecometSR131000-E2026-05-11
00841435111264TecometDB101119-A2026-05-01
00841435111288TecometDB101120-A2026-05-01
00841435124363TecometTW203060-AH2026-05-01
00818069014315TecometMA101000-A2020-08-21
00818069014476TecometSR632000-A2020-08-21
00818069013196TecometCD1020092020-08-10
00818069013226TecometCD1020122020-08-10
00818069014209TecometCD1020142020-08-10
00818069014483TecometTA1010002020-08-10
00818069014520TecometUT1010012020-08-10
00818069010225TecometCD1020022020-08-09
00818069013110TecometCD1020032020-08-09
00818069013127TecometCD1020042020-08-09
00818069014360TecometRS10205912020-08-07
00818069014377TecometRS10207872020-08-07
00818069014384TecometRS10209842020-08-07
00818069014391TecometRS10211812020-08-07
00818069014407TecometRS10213782020-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810071391460Able Medical DevicesJ.M. Longyear Manufacturing, LLCHXX2026-05-26
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00190776418328MillenniumAvalign Technologies, Inc.HXX2026-03-23
00199150039524n/aMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-22
00199150067459Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-03-20
B922F004800208ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHXX2026-03-11
G832F00500340ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
G832F00503040ACURA Stabilization SystemBioalign Inc.HXX2026-03-09
00840194498975Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00840194498982Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2026-03-03
00810076338545Momentum MIS - Modified InstrumentUlrich Medical Usa, Inc.HXX2026-03-02
00199150066902Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-02-28
03662663128780PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCHXX2026-02-11
03662663129084Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCHXX2026-02-11
00810112597493TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXX2026-02-10
00810112599756TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHXX2026-02-10
10886982351586NASynthes GmbHHXX2026-02-10
10886982351593NASynthes GmbHHXX2026-02-10
00840180545225General InstrumentsALPHATEC SPINE, INC.HXX2026-01-29
10885862657060CSBExactech, Inc.HXX2026-01-28
00840194498128Response Spine SystemORTHOPEDIATRICS CORP.HXX2026-01-22
00888118145871LEVEL ONEKLS-Martin L.P.HXX2026-01-19
08800308499696INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HXX2026-01-19
07640332471548PERLA ® TLSpineArt SAHXX2026-01-05
00840180543917General InstrumentsALPHATEC SPINE, INC.HXX2025-12-31
00840194495189Response 5.5/6.0ORTHOPEDIATRICS CORP.HXX2025-12-31
00199150060115Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00199150062898Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2025-12-29
00888480489849Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29
00888480489856Solitaire Cervical Spacer SystemHighridge Medical, LLCHXX2025-12-29