FDA.reportPublic FDA data

ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology

Primary DI
00191375049685
Brand
ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology
Company
TITAN SPINE, LLC
Model
7124-1514-N
Catalog number
7124-1514-N
Device description
Interbody Fusion Device 24 Degree 60 (M/L) 22 (A/P) 14 mm
Published
2020-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191375049685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191375049685001913750496851913750496850191375049685

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
Angle24degree
Device Size Text, specify0
Device Size Text, specify0
Height14Millimeter
Length60Millimeter
Width22Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
623316978
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M682230013150ENDOSKELETON® TAS2300-13152300-13152017-01-03
M682420001130ENDOSKELETON®4200-01134200-01132017-01-19
M682521010620ENDOSKELETON TCS5210-10625210-10622016-12-13
M682521010630ENDOSKELETON TCS5210-10635210-10632016-12-13
M682521010640ENDOSKELETON TCS5210-10645210-10642016-12-13
M682521010650ENDOSKELETON TCS5210-10655210-10652016-12-13
M682521010660ENDOSKELETON TCS5210-10665210-10662016-12-13
M682490010220ENDOSKELETON TT4900-10224900-10222016-12-08
M682790010080ENDOSKELETON TL7900-10087900-10082016-10-06
M682110000130ENDOSKELETON Posterior DPK1100-00131100-00132016-09-17
M682110000170ENDOSKELETON Posterior DPK1100-00171100-00172016-09-17
M682110000180ENDOSKELETON Posterior DPK1100-00181100-00182016-09-17
M682110000190ENDOSKELETON Posterior DPK1100-00191100-00192016-09-17
M682110000200ENDOSKELETON Posterior DPK1100-00201100-00202016-09-17
M682110000210ENDOSKELETON Posterior DPK1100-00211100-00212016-09-17
M682110000220ENDOSKELETON Posterior DPK1100-00221100-00222016-09-17
M682110000230ENDOSKELETON Posterior DPK1100-00231100-00232016-09-17
M682110000240ENDOSKELETON Anterior DPK1100-00241100-00242016-09-17
M682110000250ENDOSKELETON Posterior DPK1100-00251100-00252016-09-17
M682113010100ENDOSKELETON Sterile Barrier System1130-10101130-10102016-09-17

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