FDA.reportPublic FDA data

Spinal Jaxx Interbody Fusion Device

Primary DI
00818956021280
Brand
Spinal Jaxx Interbody Fusion Device
Company
NEUROPRO SPINAL JAXX INC.
Model
100001-566
Catalog number
100001-566
Device description
Spinal Jaxx OsteoSync Implant, 11Hx10Wx23L mm
Published
2020-04-15
Public version status
Update
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152501000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152501000Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.2016-06-29MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818956021280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818956021280008189560212808189560212800818956021280

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height11Millimeter
Length23Millimeter
Width10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
209-545-5111contact@neuroprotech.com

Regulatory Flags#

DUNS number
080554344
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818956020887Spinal Jaxx Interbody Fusion Device100001-615100001-6152020-04-15
00818956020894Spinal Jaxx Interbody Fusion Device100001-616100001-6162020-04-15
00818956020900Spinal Jaxx Interbody Fusion Device100001-617100001-6172020-04-15
00818956020917Spinal Jaxx Interbody Fusion Device100001-618100001-6182020-04-15
00818956020924Spinal Jaxx Interbody Fusion Device100001-619100001-6192020-04-15
00818956020931Spinal Jaxx Interbody Fusion Device100001-620100001-6202020-04-15
00818956020948Spinal Jaxx Interbody Fusion Device100001-621100001-6212020-04-15
00818956020955Spinal Jaxx Interbody Fusion Device100001-622100001-6222020-04-15
00818956020962Spinal Jaxx Interbody Fusion Device100001-623100001-6232020-04-15
00818956020979Spinal Jaxx Interbody Fusion Device100001-624100001-6242020-04-15
00818956020986Spinal Jaxx Interbody Fusion Device100001-625100001-6252020-04-15
00818956020993Spinal Jaxx Interbody Fusion Device100001-626100001-6262020-04-15
00818956021006Spinal Jaxx Interbody Fusion Device100001-627100001-6272020-04-15
00818956021013Spinal Jaxx Interbody Fusion Device100001-628100001-6282020-04-15
00818956021020Spinal Jaxx Interbody Fusion Device100001-629100001-6292020-04-15
00818956021037Spinal Jaxx Interbody Fusion Device100001-630100001-6302020-04-15
00818956021044Spinal Jaxx Interbody Fusion Device100001-631100001-6312020-04-15
00818956021051Spinal Jaxx Interbody Fusion Device100001-632100001-6322020-04-15
00818956021068Spinal Jaxx Interbody Fusion Device100001-633100001-6332020-04-15
00818956021075Spinal Jaxx Interbody Fusion Device100001-634100001-6342020-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283403460LumiVy™VY SPINE LLCMAX2026-06-05
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02