FDA.reportPublic FDA data

AXSOS

Primary DI
04546540693976
Brand
AXSOS
Company
Stryker GmbH
Model
703572
Catalog number
703572
Device description
Drill Sleeve
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
04546540693976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540693976045465406939764546540693976

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
07613327405743T22351-4515S2351-4515S2021-06-24
07613327697209PANGEASIT0007195SIT00071952026-08-27
07613327414127PANGEA706408S706408S2023-06-13
07613327415582PANGEA706407S706407S2023-06-13
07613327416138PANGEA706406S706406S2023-06-13
07613327539585PANGEA706444S706444S2023-06-13
07613327541731PANGEA703551S703551S2023-06-13
07613327541748PANGEA703555S703555S2023-06-13
07613154969357VARIAX45-35015S45-35015S2020-09-24
04546540195913NA1806-0083S1806-0083S2020-04-07
04546540195937NA1806-0085S1806-0085S2020-04-07
04546540195951NA1806-0090S1806-0090S2020-04-07
04546540195975NA1806-0093S1806-0093S2020-04-07
07613154633326NA45-20011S45-20011S2018-09-24
07613154633432NA45-30011S45-30011S2018-09-24
07613154665891NA45-20001S45-20001S2018-09-24
07613154665907NA45-20004S45-20004S2018-09-24
07613154665914NA45-30001S45-30001S2018-09-24
07613154665921NA45-30004S45-30004S2018-09-24
07613327083286AXSOS705077S705077S2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810161900015EARP DISC SPACER INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900022EARP INITIAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900039EARP FINAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900046RETRACTABLE OSTEOTOMERETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900053EARP BLADE 100RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900060EARP BLADE 110RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900077EARP BLADE 120RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900084EARP BLADE 130RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900091EARP BLADE 140RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900107EARP BLADE 150RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900114EARP BLADE 160RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900121EARP BLADE 170RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900138EARP BLADE 180RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900145EARP BLADE 190RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900152EARP CRADLE ASSEMBLYRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900169EARP RETRACTOR CONNECTORRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900176EARP RETRACTOR TILT REPLACEMENTRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900183EARP CUFF TRIAL 3&4MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900190EARP CUFF TRIAL 5&6MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900206EARP, TRIAL 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900213EARP, TRIAL 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900220EARP, TRIAL 14X35X10 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900237EARP, TRIAL 18X35X8 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900244EARP, TRIAL 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900251EARP, TRIAL 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900268EARP, TRIAL 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900275EARP, TRIAL 18X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900282EARP, TRIAL 18X35X12 14°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900299EARP, TRIAL 22X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900343EARP DISC SPACER, 8MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15