FDA.reportPublic FDA data

AXSOS

Primary DI
07613327073171
Brand
AXSOS
Company
Stryker GmbH
Model
705007
Catalog number
705007
Device description
Bending Iron Type 2
Published
2016-09-24
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
HWCScrew, fixation, bone
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327073171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327073171076133270731717613327073171

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
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
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27
00886385019826SR PIP17-13232017-06-27
00886385019833SR PIP17-13242017-06-27
00886385019840SR PIP17-13252017-06-27
00886385019857SR PIP17-13262017-06-27
00886385019864SR PIP17-13272017-06-27
00886385019871SR PIP17-13282017-06-27
00886385019888SR PIP17-13292017-06-27
00886385019895SR PIP17-13302017-06-27
00886385019901SR PIP17-13312017-06-27
00886385019918SR PIP17-13322017-06-27
00886385019925SR PIP17-13332017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166522816Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522823Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522830Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522847Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522854Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522861Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522878Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00889929072424Matrixx SystemNEXXT SPINE, LLCLXH2026-05-27
07640187918809Straight reamer handleMPS Micro Precision Systems AGLXH2026-05-27
07613154320271MATTAStryker GmbHHWC2023-10-20
07613154320295MATTAStryker GmbHHWC2023-10-20
07613154320301MATTAStryker GmbHHWC2023-10-20
07613154320318MATTAStryker GmbHHWC2023-10-20
07613154320424MATTAStryker GmbHHWC2023-10-20
07613154320431MATTAStryker GmbHHWC2023-10-20
07613154320448MATTAStryker GmbHHWC2023-10-20
07613154320462MATTAStryker GmbHHWC2023-10-20
07613154320486MATTAStryker GmbHHWC2023-10-20
07613154320493MATTAStryker GmbHHWC2023-10-20
07613154320509MATTAStryker GmbHHWC2023-10-20
07613154320523MATTAStryker GmbHHWC2023-10-20
07613154320554MATTAStryker GmbHHWC2023-10-20
07613154320592MATTAStryker GmbHHWC2023-10-20
07613154320615MATTAStryker GmbHHWC2023-10-20
07613154320639MATTAStryker GmbHHWC2023-10-20
07613154320646MATTAStryker GmbHHWC2023-10-20
07613154320660MATTAStryker GmbHHWC2023-10-20
07613154320684MATTAStryker GmbHHWC2023-10-20
07613154320691MATTAStryker GmbHHWC2023-10-20
07613154320769MATTAStryker GmbHHWC2023-10-20