FDA.reportPublic FDA data

EnFix Instrument Kit - TAC

Primary DI
00860015151322
Brand
EnFix Instrument Kit - TAC
Company
TETROUS, INC.
Model
TET-KT-006
Published
2026-02-11
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
FSMTray, Surgical, Instrument
HWJAwl
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
HWJAwlOrthopedic1
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015151322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015151322008600151513228600151513220860015151322

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
111821928
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014213489GuidewireTET-INS-0212026-02-24
00860015151308EnFix Instrument Kit - CompleteTET-KT-0042026-02-24
00860015151315EnFix Instrument Kit - ACLTET-KT-0052026-02-24
00860014213427Awl - Non-CuttingTET-INS-0112026-02-10
00860014213434Cutting Awl - 5.5mmTET-INS-0122026-02-10
00860014213441Cutting Awl - 4.5mmTET-INS-0132026-02-10
00860014213458Introducer ProbeTET-INS-0142026-02-10
00860014213465Instrument TrayTET-INS-0162026-02-10
00860014213472Pusher ProbeTET-INS-0202026-02-10
00860014213496Introducer Probe - SJTET-INS-0072026-02-10
00860014213403Introducer Probe - Flat CollarTET-INS-0052025-11-04
00860014213410Introducer Probe - Stepped CollarTET-INS-0042025-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449010134Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035489Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035496Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035502Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035519Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04052536218073uCentumUlrich GmbH & Co. KGHXB2026-06-09
04052536218080uCentumUlrich GmbH & Co. KGHXB2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257898Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257904Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257911Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257928Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257935Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257942Surgical DesignSurgical Design, Inc.FSM2026-06-06
00199150080304Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXB2026-06-05
00857915007750Endo ECTR TrayA.M. SURGICAL, INC.FSM2026-06-04
10705037042999STERRAD™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FSM2026-06-03
07613327605716PANGEAStryker GmbHFSM2026-06-02
00846338005474ProbeELLIQUENCE, LLCHXB2026-06-01
07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
08435389830962DRILL HOLDER FOR EXTRA SHORT DRILLSBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
07630055307736ACE Acetabular Reamer Tray - Instrument TrayIncipio Devices SAFSM2026-04-30