FDA.reportPublic FDA data

NA

Primary DI
03700569654467
Brand
NA
Company
NEWCLIP TECHNICS
Model
CAT3.5L26D-ST
Catalog number
CAT3.5L26D-ST
Published
2024-11-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K202803000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202803000Activmotion S DTONewclip Technics2021-12-16HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569654467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569654467037005696544673700569654467

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended 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, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Regulatory Flags#

DUNS number
263281904
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700569631840Alians ForearmHTSIS2HTSIS22026-10-01
03700569631857Alians ForearmHTSIS2-STHTSIS2-ST2026-10-01
03700569633943NAQBT2.8L18-STQBT2.8L18-ST2026-10-01
03700569633967NAQBT2.8L20-STQBT2.8L20-ST2026-10-01
03700569633981NAQBT2.8L22-STQBT2.8L22-ST2026-10-01
03700569634001NAQBT2.8L24-STQBT2.8L24-ST2026-10-01
03700569634025NAQBT2.8L26-STQBT2.8L26-ST2026-10-01
03700569634049NAQBT2.8L28-STQBT2.8L28-ST2026-10-01
03700569634063NAQBT2.8L30-STQBT2.8L30-ST2026-10-01
03700569602918Alians ForearmETSIS1ETSIS12024-11-14
03700569602925Alians ForearmETSIS1-STETSIS1-ST2024-11-14
03700569602932Alians ForearmETSIS2ETSIS22024-11-14
03700569602949Alians ForearmETSIS2-STETSIS2-ST2024-11-14
03700569602956Alians ForearmETSIS3ETSIS32024-11-14
03700569602963Alians ForearmETSIS3-STETSIS3-ST2024-11-14
03700569602970Alians ForearmETSIS4ETSIS42024-11-14
03700569602987Alians ForearmETSIS4-STETSIS4-ST2024-11-14
03700569604233NAQOT3.5L10-STQOT3.5L10-ST2024-11-15
03700569604257NAQOT3.5L12-STQOT3.5L12-ST2024-11-15
03700569604271NAQOT3.5L14-STQOT3.5L14-ST2024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569633943NANEWCLIP TECHNICSHWC2026-10-01
03700569633967NANEWCLIP TECHNICSHWC2026-10-01
03700569633981NANEWCLIP TECHNICSHWC2026-10-01
03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
08057717550535BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550542BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550566BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550580BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550597BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550610BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550627BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550641BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550665BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550689BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550702BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550726BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550740BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550764BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
08057717550788BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
00885556838211Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
00815432024322DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024339DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024353DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024377DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024391DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024407DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09
00815432024421DynaForce MotoBAND MaxCROSSROADS EXTREMITY SYSTEMSHWC2022-12-09