FDA.reportPublic FDA data

TiLock

Primary DI
M719GM126C600
Brand
TiLock
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GM126-C60
Device description
6.0mm Modular Short Tap - Cannulated
Published
2023-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

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
K103671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103671000GENESYS SPINE TILOCK SYSTEMGenesys Spine2011-07-21NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GM126C600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width6Millimeter

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
Lot or batch
true
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
M719IST80110C0TiLock1IS-T80110-C2026-08-18
M719IST80115C0TiLock1IS-T80115-C2026-08-18
M719IST80120C0TiLock1IS-T80120-C2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00197157116712ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116729ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116736ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116743ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116750ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116767ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116774ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116781ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116798ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116804ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116811ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116828ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116835ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116842ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116859ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116866ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116873ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116880ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116897ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116903ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116910ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116927ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116934ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116941ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116958ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116965ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116972ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116989ZAVATION SCREWZavation LLCNKB2026-09-18