FDA.reportPublic FDA data

Voom Medical REVCONTM Screw System

Primary DI
00850041704593
Brand
Voom Medical REVCONTM Screw System
Company
Voom Medical Devices, Inc
Model
RSN3020-S
Catalog number
RSN3020-S
Device description
REVCON Neutra Screw, Ø3.0x20mm, 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
00850041704593PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041704593008500417045938500417045930850041704593

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
Length20Millimeter
Outer Diameter3Millimeter

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
00850041704012Voom Medical REVCONTM Screw SystemRSA4046-SRSA4046-S2025-03-01
00850041704029Voom Medical REVCONTM Screw SystemRSA4048-SRSA4048-S2025-03-01
00850041704531Voom Medical REVCONTM Screw SystemRSA4050-SRSA4050-S2025-03-01
00850041704548Voom Medical REVCONTM Screw SystemRSA4052-SRSA4052-S2025-03-01
00850041704555Voom Medical REVCONTM Screw SystemRSA4054-SRSA4054-S2025-03-01
00850041704562Voom Medical REVCONTM Screw SystemRSA4056-SRSA4056-S2025-03-01
00850041704579Voom Medical REVCONTM Screw SystemRSA4058-SRSA4058-S2025-03-01
00850041704586Voom Medical REVCONTM Screw SystemRSA4060-SRSA4060-S2025-03-01
00850041704609Voom Medical REVCONTM Screw SystemRSN3022-SRSN3022-S2025-03-01
00850041704616Voom Medical REVCONTM Screw SystemRSN3024-SRSN3024-S2025-03-01
00850041704623Voom Medical REVCONTM Screw SystemRSN3026-SRSN3026-S2025-03-01
00850041704630Voom Medical REVCONTM Screw SystemRSN3028-SRSN3028-S2025-03-01
00850041704647Voom Medical REVCONTM Screw SystemRSN3030-SRSN3030-S2025-03-01
00850041704654Voom Medical REVCONTM Screw SystemRSN3036-SRSN3036-S2025-03-01
00850041704661Voom Medical REVCONTM Screw SystemRSN3038-SRSN3038-S2025-03-01
00850041704678Voom Medical REVCONTM Screw SystemRSN3040-SRSN3040-S2025-03-01
00850041704685Voom Medical REVCONTM Screw SystemRSN3042-SRSN3042-S2025-03-01
00850041704692Voom Medical REVCONTM Screw SystemRSN3044-SRSN3044-S2025-03-01
00850041704708Voom Medical REVCONTM Screw SystemRSN3046-SRSN3046-S2025-03-01
00850041704715Voom Medical REVCONTM Screw SystemRSN3048-SRSN3048-S2025-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662970890ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWC2026-07-10
05055662971514ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWC2026-07-10
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906309EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906316EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906323EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556901946EVOSSmith & Nephew, Inc.HWC2026-06-24
00888867460973Arthrex®ARTHREX, INC.HWC2026-06-11
00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586416CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586430CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586454CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586478CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586690CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586706CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10