FDA.reportPublic FDA data

TiLock

Primary DI
M719IST80110C0
Brand
TiLock
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
IS-T80110-C
Device description
Pre-Bent Barrell Rod, 5.5mm x 110mm
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100757000TILOCK PEDICLE SCREW SYSTEMGenesys Spine2010-07-01NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719IST80110C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
512-381-7070info@genesysspine.com

Regulatory Flags#

DUNS number
017921066
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M719GSIX1210TiLock1GSI-X1212026-08-18
M719IST80030C0TiLock1IS-T80030-C2026-08-18
M719IST80035C0TiLock1IS-T80035-C2026-08-18
M719IST80040C0TiLock1IS-T80040-C2026-08-18
M719IST80045C0TiLock1IS-T80045-C2026-08-18
M719IST80050C0TiLock1IS-T80050-C2026-08-18
M719IST80055C0TiLock1IS-T80055-C2026-08-18
M719IST80060C0TiLock1IS-T80060-C2026-08-18
M719IST80065C0TiLock1IS-T80065-C2026-08-18
M719IST80070C0TiLock1IS-T80070-C2026-08-18
M719IST80075C0TiLock1IS-T80075-C2026-08-18
M719IST80080C0TiLock1IS-T80080-C2026-08-18
M719IST80085C0TiLock1IS-T80085-C2026-08-18
M719IST80090C0TiLock1IS-T80090-C2026-08-18
M719IST80095C0TiLock1IS-T80095-C2026-08-18
M719IST80100C0TiLock1IS-T80100-C2026-08-18
M719IST80105C0TiLock1IS-T80105-C2026-08-18
M719IST80115C0TiLock1IS-T80115-C2026-08-18
M719IST80120C0TiLock1IS-T80120-C2026-08-18
M719IST80125C0TiLock1IS-T80125-C2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157120214ZAVATION SCREWZavation LLCNKB2026-10-13
00197157120221ZAVATION SCREWZavation LLCNKB2026-10-13
00197157120238ZAVATION SCREWZavation LLCNKB2026-10-13
00197157120245ZAVATION SCREWZavation LLCNKB2026-10-13
00197157120252ZAVATION SCREWZavation LLCNKB2026-10-13
00197157120269ZAVATION SCREWZavation LLCNKB2026-10-13
00197157120276ZAVATION SCREWZavation LLCNKB2026-10-13
00197157120641ZAVATION SCREWZavation LLCNKB2026-10-13
B515RSCTT5055070Swedge Curved, Transition, Titanium Rod 70mmSPINAL RESOURCES, INC.NKB2026-10-13
B515RSCTT5055080Swedge Curved, Transition, Titanium, RodSPINAL RESOURCES, INC.NKB2026-10-13
B515RSTT47555045Swedge Pedicle Screw Fixation SystemSPINAL RESOURCES, INC.NKB2026-10-13
00197157119638ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119645ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119652ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119669ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119676ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119683ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119690ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119706ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119713ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119720ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119737ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119744ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119751ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119768ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119775ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119782ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119799ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119805ZAVATION SCREWZavation LLCNKB2026-10-12
00197157119812ZAVATION SCREWZavation LLCNKB2026-10-12