FDA.reportPublic FDA data

NA

Primary DI
03700569647117
Brand
NA
Company
NEWCLIP TECHNICS
Model
CT4.5L30D-ST
Catalog number
CT4.5L30D-ST
Published
2024-11-14
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
K241539000
K261038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241539000Activmotion SNewclip Technics2024-07-30HRS
K261038000Xpert PFPNewclip Technics2026-05-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700569647117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700569647117037005696471173700569647117

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
03700569638306NASAT3.5L22SAT3.5L222024-11-15
03700569638313NASAT3.5L22-STSAT3.5L22-ST2024-11-15
03700569638320NASAT3.5L24SAT3.5L242024-11-15
03700569638337NASAT3.5L24-STSAT3.5L24-ST2024-11-15
03700569638344NASAT3.5L26SAT3.5L262024-11-15
03700569638351NASAT3.5L26-STSAT3.5L26-ST2024-11-15
03700569638368NASAT3.5L28SAT3.5L282024-11-15
03700569638375NASAT3.5L28-STSAT3.5L28-ST2024-11-15
03700569638382NASAT3.5L30SAT3.5L302024-11-15
03700569638399NASAT3.5L30-STSAT3.5L30-ST2024-11-15
03700569638405NASAT3.5L32SAT3.5L322024-11-15
03700569638412NASAT3.5L32-STSAT3.5L32-ST2024-11-15
03700569638429NASAT3.5L36SAT3.5L362024-11-15
03700569638436NASAT3.5L36-STSAT3.5L36-ST2024-11-15
03700569638443NASAT3.5L38SAT3.5L382024-11-15
03700569638450NASAT3.5L38-STSAT3.5L38-ST2024-11-15
03700569638467NASAT3.5L40SAT3.5L402024-11-15
03700569638474NASAT3.5L40-STSAT3.5L40-ST2024-11-15
03700569648770NASAT3.5L34SAT3.5L342024-11-15
03700569648787NASAT3.5L34-STSAT3.5L34-ST2024-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842078100011HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100028HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100035HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
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20810152101432DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101449DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101456DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101586DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101609DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101616DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101623DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101630DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101647DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101661DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13