FDA.reportPublic FDA data

Tritanium X

Primary DI
07613327366914
Brand
Tritanium X
Company
Stryker Corporation
Model
480220102
Catalog number
480220102
Device description
PL Straight Inserter
Published
2020-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327366914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327366914076133273669147613327366914

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
149183167
Device count
1
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
07613327554687Omnicurve1033-115-0001033-115-0002022-04-12
07613327554700Omnicurve1033-120-0001033-120-0002022-04-12
07613327638226Omnicurve10330150001033-015-0002024-09-03
07613327638240Omnicurve10320200001032-020-0002024-09-03
07613327638257Omnicurve10330300001033-030-0002024-09-03
07613327638431Omnicurve10330200001033-020-0002024-09-03
07613327638448Omnicurve10320300001032-030-0002024-09-03
07613327554649Omnicurve1032-130-0001032-130-0002023-11-02
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327554663Omnicurve1032-120-0001032-120-0002022-04-12
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011177814Wright-Out Hip Stem Extractor Guide Block and Osteotome Blade KitMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177838Wright-Out Hip Stem Extractor Slide HammerMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177845Wright-Out Hip Stem Extractor Osteotome HandleMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177852Wright-Out Hip Stem Extractor 5/64" T-Handle Hex KeyMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
00860011177869Wright-Out Hip Stem Extractor 10mm T-Handle Socket WrenchMAP MEDICAL SOLUTIONS, LLCLXH2026-07-06
03770019503416Drill - Screw D.3,5mm-L.18SC MEDICALXH2026-07-03
03770019503867Cannulated Screwdriver tip for screw D3,5mm-L.16SC MEDICALXH2026-07-03
00196449010196Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449010288Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035243Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035250Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035267Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035281Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035298Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035304Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035311Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035328Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035335Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035366Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035380Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035397Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035441Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035465Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00196449035472Anatomic Access LLIFTyber Medical, LLCLXH2026-06-09
00810094692698Modular Frog EyesTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692704Distal Femoral Cut Block ConnectorTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
00810094692933Magnet Spacer, 5mmTOTAL JOINT ORTHOPEDICS, INC.LXH2026-06-09
04052536123728mamboUlrich GmbH & Co. KGLXH2026-06-09
08809945870578BENCOXCorentec Co., LtdLXH2026-06-09
04052536085668neon3Ulrich GmbH & Co. KGLXH2026-06-08