FDA.reportPublic FDA data

ENDOSKELETON TA

Primary DI
M682210692100
Brand
ENDOSKELETON TA
Company
TITAN SPINE, LLC
Model
2106-9210
Catalog number
2106-9210
Device description
7 DEG LORDOTIC, TRIAL, LARGE, 10MM
Published
2016-09-17
Public version status
Update
Distribution status
Not 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
K080615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080615000ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD)Titan Spine, LLC2008-06-17MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M682210692100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree
Depth24Millimeter
Device Size Text, specify0
Device Size Text, specify0
Height10Millimeter
Width36Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(262)242-7801productinfo@titanspine.com

Regulatory Flags#

DUNS number
623316978
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M682210701100Endoskeleton TA2107-01102107-01102015-09-17
M682210701110Endoskeleton TA2107-01112107-01112015-09-17
M682210701120Endoskeleton TA2107-01122107-01122015-09-17
M682210701130Endoskeleton TA2107-01132107-01132015-09-17
M682210701140Endoskeleton TA2107-01142107-01142015-09-17
M682210701150Endoskeleton TA2107-01152107-01152015-09-17
M682210701160Endoskeleton TA2107-01162107-01162015-09-17
M682210701170Endoskeleton TA2107-01172107-01172015-09-17
M682210701180Endoskeleton VBR2107-01182107-01182015-09-17
M682210701200Endoskeleton VBR2107-01202107-01202015-09-17
M682210702100Endoskeleton TA2107-02102107-02102015-09-17
M682210702110Endoskeleton TA2107-02112107-02112015-09-17
M682210702120Endoskeleton TA2107-02122107-02122015-09-17
M682210702130Endoskeleton TA2107-02132107-02132015-09-17
M682210702140Endoskeleton TA2107-02142107-02142015-09-17
M682210702150Endoskeleton TA2107-02152107-02152015-09-17
M682210702160Endoskeleton TA2107-02162107-02162015-09-17
M682210702170Endoskeleton TA2107-02172107-02172015-09-17
M682210702180Endoskeleton VBR2107-02182107-02182015-09-17
M682210702200Endoskeleton VBR2107-02202107-02202015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719GLL100QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL101QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL106QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
M719GLL107QC03DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-07-14
08800043913099N/ATDM Co., Ltd.MAX2026-06-10
08800043913105N/ATDM Co., Ltd.MAX2026-06-10
08800043913112N/ATDM Co., Ltd.MAX2026-06-10
08800043913129N/ATDM Co., Ltd.MAX2026-06-10
08800043913136N/ATDM Co., Ltd.MAX2026-06-10
08800043913143N/ATDM Co., Ltd.MAX2026-06-10
08800043913150N/ATDM Co., Ltd.MAX2026-06-10
08800043913167N/ATDM Co., Ltd.MAX2026-06-10
08800043913174N/ATDM Co., Ltd.MAX2026-06-10
08800043913181N/ATDM Co., Ltd.MAX2026-06-10
08800043913198N/ATDM Co., Ltd.MAX2026-06-10
08800043913204N/ATDM Co., Ltd.MAX2026-06-10
08800043913211N/ATDM Co., Ltd.MAX2026-06-10
08800043917288N/ATDM Co., Ltd.MAX2026-06-10
08800043917295N/ATDM Co., Ltd.MAX2026-06-10
08800043917301N/ATDM Co., Ltd.MAX2026-06-10
08800043917318N/ATDM Co., Ltd.MAX2026-06-10
08800043917325N/ATDM Co., Ltd.MAX2026-06-10
08800043917332N/ATDM Co., Ltd.MAX2026-06-10
08800043917349N/ATDM Co., Ltd.MAX2026-06-10
08800043967177N/ATDM Co., Ltd.MAX2026-06-10
08800043967184N/ATDM Co., Ltd.MAX2026-06-10
08800043967191N/ATDM Co., Ltd.MAX2026-06-10
08800043967207N/ATDM Co., Ltd.MAX2026-06-10
08800043967214N/ATDM Co., Ltd.MAX2026-06-10
08800043967221N/ATDM Co., Ltd.MAX2026-06-10