FDA.reportPublic FDA data

Voom Medical REVCONTM Screw System

Primary DI
00850041704517
Brand
Voom Medical REVCONTM Screw System
Company
Voom Medical Devices, Inc
Model
RSA4058
Catalog number
RSA4058
Device description
REVCON Anchor Screw, Ø4.0x58mm
Published
2025-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00850041704517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041704517008500417045178500417045170850041704517

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
Length58Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
119350516
Device count
1
Lot or batch
true
Sterilization required before use
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
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00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
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
00810112593075TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593082TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593099TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593105TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593112TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593129TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593136TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593143TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593150TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593167TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593174TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593181TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593198TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22