FDA.reportPublic FDA data

Expandable Lumbar Fusion Cage-Type I

Primary DI
06942438523888
Brand
Expandable Lumbar Fusion Cage-Type I
Company
Shanghai Reach Medical Instrument Co., Ltd
Model
F0301-B0028A956
Published
2024-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

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
K232069000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232069000Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.2023-11-29MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942438523888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942438523888069424385238886942438523888

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
530695344
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06941312465719Sterile Posterior Spinal Fixation SystemSB211-351502026-05-31
06941312466013Sterile Posterior Spinal Fixation SystemSB211-321052026-05-31
06941312466020Sterile Posterior Spinal Fixation SystemSB211-321102026-05-31
06941312466037Sterile Posterior Spinal Fixation SystemSB211-321202026-05-31
06941312466044Sterile Posterior Spinal Fixation SystemSB211-321302026-05-31
06941312466051Sterile Posterior Spinal Fixation SystemSB211-321402026-05-31
06941312466068Sterile Posterior Spinal Fixation SystemSB211-321502026-05-31
06941312466075Sterile Posterior Spinal Fixation SystemSB211-322002026-05-31
06941312466082Sterile Posterior Spinal Fixation SystemSB211-323002026-05-31
06941312466099Sterile Posterior Spinal Fixation SystemSB217-303402026-05-31
06941312466105Sterile Posterior Spinal Fixation SystemSB217-303502026-05-31
06941312466112Sterile Posterior Spinal Fixation SystemSB217-303602026-05-31
06941312466129Sterile Posterior Spinal Fixation SystemSB217-303702026-05-31
06941312466136Sterile Posterior Spinal Fixation SystemSB217-303802026-05-31
06941312466143Sterile Posterior Spinal Fixation SystemSB216-010952026-05-31
06941312465474Sterile Posterior Spinal Fixation SystemSB211-341502026-05-28
06941312465481Sterile Posterior Spinal Fixation SystemSB211-342002026-05-28
06941312465917Sterile Posterior Spinal Fixation SystemSB211-320552026-05-28
06941312465924Sterile Posterior Spinal Fixation SystemSB211-320602026-05-28
06941312465931Sterile Posterior Spinal Fixation SystemSB211-320652026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationMAX2015-09-14
07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14