FDA.reportPublic FDA data

Spinal Jaxx Interbody Fusion Device

Primary DI
00818956020870
Brand
Spinal Jaxx Interbody Fusion Device
Company
NEUROPRO SPINAL JAXX INC.
Model
100001-300
Catalog number
100001-300
Device description
Endplate Rasp
Published
2017-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00818956020870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818956020870008189560208708189560208700818956020870

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
080554344
Device count
1
Lot or batch
true
Sterilization required before use
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
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
08800043964268N/ATDM Co., Ltd.MAX2026-06-02