FDA.reportPublic FDA data

Stature®

Primary DI
M681STF0170140
Brand
Stature®
Company
ATLAS SPINE, INC.
Model
STF-017-014
Catalog number
STF-017-014
Device description
17mm Non-Lordotic Spacer
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M681STF0170140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric 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 non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] 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
Height17Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
140801007
Device count
1
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
M68111230100070HiJAK™ Stand Alone1123-01-00071123-01-00072020-09-23
M68111230100080HiJAK™ Stand Alone1123-01-00081123-01-00082020-09-23
M68111230100090HiJAK™ Stand Alone1123-01-00091123-01-00092020-09-23
M68111230100100HiJAK™ Stand Alone1123-01-00101123-01-00102020-09-23
M68111230100110HiJAK™ Stand Alone1123-01-00111123-01-00112020-09-23
M68111230100120HiJAK™ Stand Alone1123-01-00121123-01-00122020-09-23
M68111230100130HiJAK™ Stand Alone1123-01-00131123-01-00132020-09-23
M68111230100140HiJAK™ Stand Alone1123-01-00141123-01-00142020-09-23
M68111230200070HiJAK™ Stand Alone1123-02-00071123-02-00072020-09-23
M68111230200080HiJAK™ Stand Alone1123-02-00081123-02-00082020-09-23
M68111230200090HiJAK™ Stand Alone1123-02-00091123-02-00092020-09-23
M68111230200100HiJAK™ Stand Alone1123-02-00101123-02-00102020-09-23
M68111230200110HiJAK™ Stand Alone1123-02-00111123-02-00112020-09-23
M68111230200120HiJAK™ Stand Alone1123-02-00121123-02-00122020-09-23
M68111230200130HiJAK™ Stand Alone1123-02-00131123-02-00132020-09-23
M68111230200140HiJAK™ Stand Alone1123-02-00141123-02-00142020-09-23
M68111230300080HiJAK™ Stand Alone1123-03-00081123-03-00082020-09-23
M68111230300090HiJAK™ Stand Alone1123-03-00091123-03-00092020-09-23
M68111230300100HiJAK™ Stand Alone1123-03-00101123-03-00102020-09-23
M68111230300110HiJAK™ Stand Alone1123-03-00111123-03-00112020-09-23

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
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
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