FDA.reportPublic FDA data

Trauma Fixation Systems

Primary DI
00887868507243
Brand
Trauma Fixation Systems
Company
Biomet Orthopedics, LLC
Model
430031T
Catalog number
430031T
Published
2021-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXWBENDER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868507243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868507243008878685072438878685072430887868507243

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24
00880304434370Vanguard® Knee System1842811842812015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840180546178General InstrumentsALPHATEC SPINE, INC.HXW2026-05-15
00840180546192General InstrumentsALPHATEC SPINE, INC.HXW2026-05-15
08800089476886Surgical InstrumentJeil Medical CorporationHXW2026-04-09
08800089476893Surgical InstrumentJeil Medical CorporationHXW2026-04-09
00810111225281Instrument TrayTreace Medical Concepts, Inc.HXW2026-03-30
07640332475553CURE 2.0 ACPSpineArt SAHXW2025-11-12
07640375234834PERLA ® TLSpineArt SAHXW2025-11-10
07640375234841PERLA ® TLSpineArt SAHXW2025-11-10
07640375234858PERLA ® TLSpineArt SAHXW2025-11-10
07640375234865PERLA ® TLSpineArt SAHXW2025-11-10
10705034576985N/ADEPUY SPINE, LLCHXW2024-12-16
10887587077635NASynthes GmbHHXW2024-08-21
10887587077963NASynthes GmbHHXW2024-08-21
00763000733117Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2022-12-18
00643169273559n/aMEDTRONIC SOFAMOR DANEK, INC.HXW2022-11-14
00613994860415Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2022-10-10
00613994860422Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXW2022-10-10
G079C5040000010Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000020Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
G079C5040000030Golden Isles Pedicle Screw SystemIntelivation, LLCHXW2022-09-23
08800089415212INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089417308INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089418268INLET System Surgical InstrumentJeil Medical CorporationHXW2021-11-18
08800089402755Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHXW2021-05-28
10886982277022NASynthes GmbHHXW2020-12-11
10884389956212MedlineMEDLINE INDUSTRIES, INC.HXW2020-08-21
20705034734191NASynthes GmbHHXW2019-12-18
20705034734214NASynthes GmbHHXW2019-08-20
20705034734221NASynthes GmbHHXW2019-08-20
10705034548470NADEPUY SPINE, LLCHXW2019-02-20