FDA.reportPublic FDA data

INDEPENDENCE MIS

Primary DI
00889095309997
Brand
INDEPENDENCE MIS
Company
GLOBUS MEDICAL, INC.
Model
3135.0115
Device description
INDEPENDENCE MIS SPACER, 24 x 30mm 8°, 15mm
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160597000INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016-08-29OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095309997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095309997008890953099978890953099970889095309997

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193982003630N/A6190.00266190.00262026-08-14
00193982016340N/A6178.01676178.01672026-08-14
00193982096274ANTHEM2170.10362170.10362026-08-14
00193982096298ANTHEM2170.10382170.10382026-08-14
00193982096311ANTHEM2170.10402170.10402026-08-14
00193982101909ANTHEM2170.20362170.20362026-08-14
00193982101923ANTHEM2170.20382170.20382026-08-14
00193982101947ANTHEM2170.20402170.20402026-08-14
00193982141097HEDRON1208.0109S1208.0109S2026-08-14
00193982141103HEDRON1208.0111S1208.0111S2026-08-14
00193982141110HEDRON1208.0113S1208.0113S2026-08-14
00193982141127HEDRON1208.0115S1208.0115S2026-08-14
00193982141134HEDRON1208.0117S1208.0117S2026-08-14
00193982141141HEDRON1208.0211S1208.0211S2026-08-14
00193982141158HEDRON1208.0213S1208.0213S2026-08-14
00193982141165HEDRON1208.0215S1208.0215S2026-08-14
00193982141172HEDRON1208.0217S1208.0217S2026-08-14
00193982141189HEDRON1208.0313S1208.0313S2026-08-14
00193982141196HEDRON1208.0315S1208.0315S2026-08-14
00193982141202HEDRON1208.0317S1208.0317S2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B707125355730300DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730400DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730500DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730600DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730800DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731000DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731200DUALX DUAL PORTAL DISPOSABLE KIT-120MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
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00763000703950MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
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00763000704025MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
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00763000704117MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
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00763000704148MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
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