FDA.report

REDEMPTION Beaming System

Primary DI
00841731131676
Brand
REDEMPTION Beaming System
Company
VILEX LLC
Model
RFT50-125T-15
Catalog number
RFT50-125T-15
Device description
Screw, Compression Full Thread 5.0x125mm
Published
2024-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K221342000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K221342000REDEMPTION Beaming SystemVilex, LLC2022-12-13HWC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841731131676PrimaryGS10

GMDN Terms

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
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 DIBrandModelCatalogPublished
00841731135490TITANEXART-HD65-40ART-HD65-402026-03-03
00841731147431OPTIXOX2-0011OX2-00112026-03-03
00841731149077DYNEX MICROMR-900-PE-04MR-900-PE-042026-03-03
00841731137548TITANEX TH20-16T-092026-02-09
00841731137555TITANEX TH20-18T-092026-02-09
00841731137562TITANEX TH20-20T-092026-02-09
00841731137579TITANEX TH20-22T-092026-02-09
00841731137586TITANEX TH20-24T-092026-02-09
00841731137593TITANEX TH20-26T-092026-02-09
00841731137609TITANEX TH20-28T-092026-02-09
00841731137616TITANEX TH20-30T-092026-02-09
00841731137623TITANEX TH20-32T-092026-02-09
00841731137630TITANEX TH20-34T-092026-02-09
00841731137647TITANEX TH20-36T-092026-02-09
00841731137654TITANEX TH20-38T-092026-02-09
00841731137661TITANEX TH20-40T-092026-02-09
00841731137678TITANEX TH20-42T-092026-02-09
00841731137685TITANEX TH20-44T-092026-02-09
00841731137692TITANEX TH20-46T-092026-02-09
00841731137708TITANEX TH20-48T-092026-02-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810211040227Headed Screw Partially Threaded Short 3.0mm,30mm LengthPace Surgical, Inc.HWC2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529090Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529113Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529151Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529182Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529212Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529373Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529434Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529441Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529526Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531918Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531932Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531949Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531963Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531970Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531987Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532007Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532069Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532137Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532281Arthrex®ARTHREX, INC.HWC2026-03-16
04053613298315Guide Pin SmoothGebr. Brasseler GmbH & Co. KGHWC2026-03-11
00840124525474PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00840124525481PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00841506141442Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HWC2026-03-05