FDA.reportPublic FDA data

Activ Fuse

Primary DI
03700569636913
Brand
Activ Fuse
Company
NEWCLIP TECHNICS
Model
CT4.0L18D-ST
Catalog number
CT4.0L18D-ST
Published
2024-11-14
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
K202307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202307000Activ FuseNewclip Technics2020-11-17HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569636913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569636913037005696369133700569636913

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
03700569605063Newclip InstrumentsANC841ANC8412026-05-12
03700569605070Newclip InstrumentsANC843ANC8432026-05-12
03700569605087Newclip InstrumentsANC842ANC8422026-05-12
03700569605094Newclip InstrumentsANC838ANC8382026-05-12
03700569605100Newclip InstrumentsANC839ANC8392026-05-12
03700569610555Newclip InstrumentsANC808ANC8082026-05-12
03700569610579Newclip InstrumentsANC845ANC8452026-05-12
03700569611361Newclip InstrumentsANC740ANC7402026-05-12
03700569611378Newclip InstrumentsANC739ANC7392026-05-12
03700569611385Newclip InstrumentsANC738ANC7382026-05-12
03700569611392Newclip InstrumentsANC737ANC7372026-05-12
03700569612740Newclip InstrumentsANC741ANC7412026-05-12
03700569619435Newclip InstrumentsANC657ANC6572026-05-12
03700569621759Newclip InstrumentsANC652ANC6522026-05-12
03700569621766Newclip InstrumentsANC652ANC6522026-05-12
03700569622633Newclip InstrumentsANC614/BANC614/B2026-05-12
03700569622640Newclip InstrumentsANC614/CANC614/C2026-05-12
03700569622664Newclip InstrumentsANC620ANC6202026-05-12
03700569622671Newclip InstrumentsANC621ANC6212026-05-12
03700569622688Newclip InstrumentsANC622ANC6222026-05-12

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Primary DI, Brand, Company table
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07613154320691MATTAStryker GmbHHWC2023-10-20
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07613154320776MATTAStryker GmbHHWC2023-10-20
07613154320820MATTAStryker GmbHHWC2023-10-20
07613154320837MATTAStryker GmbHHWC2023-10-20
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