FDA.reportPublic FDA data

FUSE ™ SPINAL SYSTEM

Primary DI
00643169245488
Brand
FUSE ™ SPINAL SYSTEM
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
2881324
Device description
CAGE 2881324 FUSE 13MM X 24MM 8DEG
Published
2015-06-30
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
K121288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121288000FUSE CAGEAdvanced Medical Technologies AG2012-06-29MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169245488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169245488006431692454886431692454880643169245488

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
Angle8degree
Height13Millimeter
Length24Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30
20763000211015Medtronic Reusable Instrument65501022022-10-16
20763000211039Medtronic Reusable Instrument65502022022-10-16
00763000311667KYPHON® Directional Bone Filler DeviceF04C2020-11-06
00763000311681KYPHON® EXPRESS™ Bone Filler DeviceF06A2020-11-06
00763000311698KYPHON® EXPRESS™ Directional Bone Filler DeviceF06B2020-11-06
0076300031183413 Ga TampVPT02A2020-11-06
00763000883478N/a7480757T2025-06-01
00763000883485N/a7480758T2025-06-01
00763000711993N/A65500422024-12-28
00763000712006N/A65500432024-12-28
00763000712013N/A65500442024-12-28
00763000712020n/a65500452024-12-28
00763000311650KYPHON® Bone Filler Device (BFD)F04B2020-11-06
20643169842735KYPHON ELEMENT™ Balloon Kyphoplasty System7480703T2023-06-03
00613994946393n/aEX08108162022-11-21
00643169100725Medtronic Reusable InstrumentsCDS3A2022-10-15
00643169100749Medtronic Reusable InstrumentsCDS2A2022-10-15
00643169100756KYPHON® Cement Delivery SystemCC02A2022-10-15
00763000590970Kyphon VuE Bone Cement and Kyphon MixerCT01B2022-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809974809440Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809457Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809464Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809471Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809488Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809495Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809501Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809518Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809525Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809532Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809549Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809556Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809563Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809570Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809587Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809594Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809600Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809617Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809624Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809631Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809648Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809655Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974809662Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974818879Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974836231Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974836286Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974837856Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974837955Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974839355Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974849590Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19