FDA.reportPublic FDA data

Voom Medical REVCONTM Screw System

Primary DI
00850041704555
Brand
Voom Medical REVCONTM Screw System
Company
Voom Medical Devices, Inc
Model
RSA4054-S
Catalog number
RSA4054-S
Device description
REVCON Anchor Screw, Ø4.0x54mm, Sterile
Published
2025-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K223392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223392000REVCON (TM) Screw SystemVoom Medical Devices, Inc.2023-02-28HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850041704555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041704555008500417045558500417045550850041704555

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length54Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-372-5489info@voommedicaldevices.com

Regulatory Flags#

DUNS number
119350516
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041704005REVCONVTR01000VTR010002023-04-05
00850041704036REVCONVKW01000VKW010002023-04-05
00850041704043REVCONVKW01001VKW010012023-04-05
00850041704050REVCONVEL01000VEL010002023-04-05
00850041704067REVCONVEL01001VEL010012023-04-05
00850041704074REVCONVDG01000VDG010002023-04-05
00850041704081REVCONVDB01000VDB010002023-04-05
00850041704098REVCONVDB01001VDB010012023-04-05
00850041704104REVCONVDR01000VDR010002023-04-05
00850041704111REVCONVDR01001VDR010012023-04-05
00850041704128REVCONVHA01000VHA010002023-04-05
00850041704135REVCONVHA01001VHA010012023-04-05
00850041704142REVCONRSN3020RSN30202023-04-05
00850041704159REVCONRSN3022RSN30222023-04-05
00850041704166REVCONRSN3024RSN30242023-04-05
00850041704173REVCONRSN3026RSN30262023-04-05
00850041704180REVCONRSN3028RSN30282023-04-05
00850041704197REVCONRSN3030RSN30302023-04-05
00850041704203REVCONRSN3032RSN30322023-04-05
00850041704210REVCONRSN3034RSN30342023-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112599275TriLEAPSynthes GmbHHWC2025-03-20
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00810112599206TriLEAPSynthes GmbHHWC2025-03-17
00810112599213TriLEAPSynthes GmbHHWC2025-03-17
00810112599220TriLEAPSynthes GmbHHWC2025-03-17
00810112599237TriLEAPSynthes GmbHHWC2025-03-17
00810112599244TriLEAPSynthes GmbHHWC2025-03-17
00810112599251TriLEAPSynthes GmbHHWC2025-03-17
00810112599268TriLEAPSynthes GmbHHWC2025-03-17
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
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00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
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00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593051TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593068TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22