FDA.reportPublic FDA data

SUBFIX

Primary DI
07613252263524
Brand
SUBFIX
Company
Stryker GmbH
Model
SUT0080
Catalog number
SUT0080
Device description
Arthroeresis Implant
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093820000SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies2010-05-19HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252263524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252263524076132522635247613252263524

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone staple, non-adjustable, non-sterileA non-sterile, non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Disposable devices associated with implantation may be included.

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07613327083323AXSOS705078S705078S2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131639CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
10886982342508VOLTSynthes GmbHHWC2026-09-25
10886982342515VOLTSynthes GmbHHWC2026-09-25
10886982342522VOLTSynthes GmbHHWC2026-09-25
10886982342539VOLTSynthes GmbHHWC2026-09-25
10886982342546VOLTSynthes GmbHHWC2026-09-25
10886982342553VOLTSynthes GmbHHWC2026-09-25
10886982342560VOLTSynthes GmbHHWC2026-09-25
10886982342577VOLTSynthes GmbHHWC2026-09-25
10886982342584VOLTSynthes GmbHHWC2026-09-25
10886982342591VOLTSynthes GmbHHWC2026-09-25