FDA.report

Xstim

Primary DI
00850047248015
Brand
Xstim
Company
Xstim, Inc
Model
07-5000
Device description
Xstim Electrodes
Published
2024-08-16
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
LOFStimulator, Bone Growth, Non-Invasive

Product Code Classifications

CodeDeviceSpecialtyClass
LOFStimulator, Bone Growth, Non-InvasiveUnknown3

Premarket Submissions

SubmissionSupplement
P230025000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
P230025000Xstim Spine Fusion StimulatorXstim, Inc.2024-02-09LOF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850047248015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047248015008500472480158500472480150850047248015

GMDN Terms

TermDefinition
Patient-worn bone growth electromagnetic stimulatorA battery-powered, body-worn device designed to apply an electrical stimulus directly to bone to promote bone formation (i.e., osteogenesis). It is intended to generate an electromagnetic (EM) field (and its associated induced voltage effects) around a fracture or fusion site; it is not intended to apply an electric current directly to the body. The device is used as an alternative to bone grafting for non-union fractures (a condition in which the ends of a fractured bone fail to unite), and as a spinal fusion adjunct in treating degenerative vertebral diseases. It is also known as an osteogenesis stimulator.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119283921
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10850047248005Xstim08-00412024-08-16
00850047248022Xstim03-50052024-08-16
00850047248039Xstim07-50072024-08-16
00850047248046Xstim07-50062024-08-16
00850047248053Xstim07-50022024-08-16
00850047248060Xstim07-50032024-08-16
00850047248077Xstim07-50042024-08-16
00850047248084Xstim07-50052024-08-16
00850047248091Xstim07-50012024-08-16

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10850047248005XstimXstim, IncLOF2024-08-16
00850047248022XstimXstim, IncLOF2024-08-16
00850047248039XstimXstim, IncLOF2024-08-16
00850047248046XstimXstim, IncLOF2024-08-16
00850047248053XstimXstim, IncLOF2024-08-16
00850047248060XstimXstim, IncLOF2024-08-16
00850047248077XstimXstim, IncLOF2024-08-16
00850047248084XstimXstim, IncLOF2024-08-16
00850047248091XstimXstim, IncLOF2024-08-16
18257200158706AccelStimOrthofix US LLCLOF2023-06-12
18257200158713AccelStimOrthofix US LLCLOF2023-06-12
18257200158720AccelStimOrthofix US LLCLOF2023-06-12
08050040997336AccelstimIGEA SPALOF2022-11-04
08050040997299AccelstimIGEA SPALOF2022-08-30
08050040997305AccelstimIGEA SPALOF2022-08-30
08050040997312AccelstimIGEA SPALOF2022-08-30
08050040997329AccelstimIGEA SPALOF2022-08-30
08050040997213AccelStimIGEA SPALOF2022-07-14
M937710346601EXOGEN Metatarsal StrapBIOVENTUS LLCLOF2021-12-17
00850372007165ActaStim-S THERAGEN, LLCLOF2021-02-08
00850372007172ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007189ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007196ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007202ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007219ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007226ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007233ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007240ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007257ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007264ActaStim-STHERAGEN, LLCLOF2021-02-08