FDA.reportPublic FDA data

REDEMPTION Beaming System

Primary DI
00841731131805
Brand
REDEMPTION Beaming System
Company
VILEX LLC
Model
RFT65-95T-24
Catalog number
RFT65-95T-24
Device description
Screw, Compression Full Thread 6.5x95mm
Published
2024-03-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K221342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221342000REDEMPTION Beaming SystemVilex, LLC2022-12-13HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731131805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731131805008417311318058417311318050841731131805

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117502293
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841731131690REDEMPTION Beaming SystemRFT65-40T-24RFT65-40T-242024-03-08
00841731131706REDEMPTION Beaming SystemRFT65-45T-24RFT65-45T-242024-03-08
00841731131713REDEMPTION Beaming SystemRFT65-50T-24RFT65-50T-242024-03-08
00841731131720REDEMPTION Beaming SystemRFT65-55T-24RFT65-55T-242024-03-08
00841731131737REDEMPTION Beaming SystemRFT65-60T-24RFT65-60T-242024-03-08
00841731131744REDEMPTION Beaming SystemRFT65-65T-24RFT65-65T-242024-03-08
00841731131751REDEMPTION Beaming SystemRFT65-70T-24RFT65-70T-242024-03-08
00841731131768REDEMPTION Beaming SystemRFT65-75T-24RFT65-75T-242024-03-08
00841731131775REDEMPTION Beaming SystemRFT65-80T-24RFT65-80T-242024-03-08
00841731131782REDEMPTION Beaming SystemRFT65-85T-24RFT65-85T-242024-03-08
00841731131799REDEMPTION Beaming SystemRFT65-90T-24RFT65-90T-242024-03-08
00841731147431OPTIXOX2-0011OX2-00112026-03-03
00841731140395ARTEMIS FUZEAV40-20T-16V2026-07-22
00841731140401ARTEMIS FUZEAV40-22T-16V2026-07-22
00841731140418ARTEMIS FUZEAV40-24T-16V2026-07-22
00841731140425ARTEMIS FUZEAV40-26T-16V2026-07-22
00841731140432ARTEMIS FUZEAV40-28T-16V2026-07-22
00841731140449ARTEMIS FUZEAV40-30T-16V2026-07-22
00841731140456ARTEMIS FUZEAV40-32T-16V2026-07-22
00841731140463ARTEMIS FUZEAV40-34T-16V2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894821714APTUSMedartis AGHWC2026-10-27
07630894821721APTUSMedartis AGHWC2026-10-27
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07630894821769APTUSMedartis AGHWC2026-10-27
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07630894821790APTUSMedartis AGHWC2026-10-27
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07630894821813APTUSMedartis AGHWC2026-10-27
07630894821820APTUSMedartis AGHWC2026-10-27
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07630894821899APTUSMedartis AGHWC2026-10-27
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07630894822018APTUSMedartis AGHWC2026-10-27
07630894822032APTUSMedartis AGHWC2026-10-27
07630894822056APTUSMedartis AGHWC2026-10-27
07630894822070APTUSMedartis AGHWC2026-10-27
07630894822094APTUSMedartis AGHWC2026-10-27
07630894822117APTUSMedartis AGHWC2026-10-27
07630894822131APTUSMedartis AGHWC2026-10-27
07630894822155APTUSMedartis AGHWC2026-10-27
07630894822179APTUSMedartis AGHWC2026-10-27