FDA.reportPublic FDA data

REVCON

Primary DI
00850041704395
Brand
REVCON
Company
Voom Medical Devices, Inc
Model
RSN4058
Catalog number
RSN4058
Device description
REVCON Screw, Ø4.0x58mm
Published
2023-04-05
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

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
00850041704395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041704395008500417043958500417043950850041704395

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

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
844-372-5849info@voomdevices.com

Regulatory Flags#

DUNS number
080898988
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
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
00850041704593Voom Medical REVCONTM Screw SystemRSN3020-SRSN3020-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
00888867532014Arthrex®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