Activ Ankle

Primary DI
03700569626075
Brand
Activ Ankle
Company
NEWCLIP TECHNICS
Model
CT2.8L42-ST
Catalog number
CT2.8L42-ST
Published
2024-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
K173641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173641000Activ AnkleNewclip Technics2018-01-16HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569626075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569626075037005696260753700569626075

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
263281904
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569658212Xpert PFPFT5.6D-STFT5.6D-ST2026-06-03
00370056966385Xpert PFPQTDE1D-STQTDE1D-ST2026-06-02
03700569658151Xpert PFPQTDP-E1D-STQTDP-E1D-ST2026-06-02
03700569658175Xpert PFPQTDP-E2D-STQTDP-E2D-ST2026-06-02
03700569658199Xpert PFPQTGPH2D-STQTGPH2D-ST2026-06-02
03700569662202Xpert PFPQTSM1D-STQTSM1D-ST2026-06-02
03700569663247Xpert PFPQTDE2D-STQTDE2D-ST2026-06-02
03700569663841Xpert PFPQTGE2D-STQTGE2D-ST2026-06-02
03700569663865Xpert PFPQTDE3D-STQTDE3D-ST2026-06-02
03700569663872Xpert PFPQTDP1D-STQTDP1D-ST2026-06-02
03700569663889Xpert PFPQTDP2D-STQTDP2D-ST2026-06-02
03700569663896Xpert PFPQTDP3D-STQTDP3D-ST2026-06-02
03700569663902Xpert PFPQTGP3D-STQTGP3D-ST2026-06-02
03700569663919Xpert PFPQTGP2D-STQTGP2D-ST2026-06-02
03700569663926Xpert PFPQTGP1D-STQTGP1D-ST2026-06-02
03700569663933Xpert PFPQTGE1D-STQTGE1D-ST2026-06-02
03700569663940Xpert PFPQTGE3D-STQTGE3D-ST2026-06-02
03700569663964Xpert PFPQTSM3D-STQTSM3D-ST2026-06-02
03700569671327Xpert PFPQTGP-E1D-STQTGP-E1D-ST2026-06-02
03700569676438Xpert PFPQTDPH1D-STQTDPH1D-ST2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906309EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906316EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906323EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556901946EVOSSmith & Nephew, Inc.HWC2026-06-24
00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586416CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586430CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586454CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586478CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586690CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586706CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586713CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586720CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586737CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10