FDA.reportPublic FDA data

Expandable Lumbar Fusion Cage-Type I

Primary DI
06942438535751
Brand
Expandable Lumbar Fusion Cage-Type I
Company
Shanghai Reach Medical Instrument Co., Ltd
Model
F0301-B0032AC5C
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
06942438535751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942438535751069424385357516942438535751

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
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
06941312465948Sterile Posterior Spinal Fixation SystemSB211-320702026-05-28
06941312465955Sterile Posterior Spinal Fixation SystemSB211-320752026-05-28
06941312465962Sterile Posterior Spinal Fixation SystemSB211-320802026-05-28
06941312465979Sterile Posterior Spinal Fixation SystemSB211-320852026-05-28
06941312465986Sterile Posterior Spinal Fixation SystemSB211-320902026-05-28
06941312465993Sterile Posterior Spinal Fixation SystemSB211-320952026-05-28
06941312466006Sterile Posterior Spinal Fixation SystemSB211-321002026-05-28
06941312465559Sterile Posterior Spinal Fixation SystemSB211-350702026-05-22
06941312465566Sterile Posterior Spinal Fixation SystemSB211-350752026-05-22
06941312465573Sterile Posterior Spinal Fixation SystemSB211-350802026-05-22
06941312465580Sterile Posterior Spinal Fixation SystemSB211-350852026-05-22
06941312465597Sterile Posterior Spinal Fixation SystemSB211-350902026-05-22
06941312465603Sterile Posterior Spinal Fixation SystemSB211-350952026-05-22
06941312465610Sterile Posterior Spinal Fixation SystemSB211-351002026-05-22
06941312465627Sterile Posterior Spinal Fixation SystemSB211-351052026-05-22

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Primary DI, Brand, Company table
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