FDA.reportPublic FDA data

Titamed Spinal System

Primary DI
06009699901777
Brand
Titamed Spinal System
Company
TITAMED (PTY) LTD
Model
HL8S-T
Catalog number
HL8S-T
Device description
Single-use non-sterile implantable large straight tapered laminar hook intended for posterior spinal fixation systems.
Published
2026-05-28
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
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070385000TI-TAMED SPINAL SYSTEMTi-Tamed (Pty), Ltd.2009-07-31NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06009699901777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009699901777060096999017776009699901777

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system hookAn implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design 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 typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+27845070500andre@titamed.co.za

Regulatory Flags#

DUNS number
635580744
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
06009699900008Titamed Spinal SystemHL4A-THL4A-T2026-05-28
06009699900503Titamed Spinal SystemHL5Lt4-THL5Lt4-T2026-05-28
06009699900817Titamed Spinal SystemLGLG2026-05-28
06009699900831Titamed Spinal SystemRR40RR402026-05-28
06009699900848Titamed Spinal SystemRR45RR452026-05-28
06009699900855Titamed Spinal SystemRR50RR502026-05-28
06009699900862Titamed Spinal SystemRR55RR552026-05-28
06009699900879Titamed Spinal SystemRR60RR602026-05-28
06009699900886Titamed Spinal SystemRR70RR702026-05-28
06009699900893Titamed Spinal SystemRR80RR802026-05-28
06009699900909Titamed Spinal SystemRR90RR902026-05-28
06009699900916Titamed Spinal SystemRR100RR1002026-05-28
06009699900923Titamed Spinal SystemRR1000RR10002026-05-28
06009699900930Titamed Spinal SystemHL5Rt4-THL5Rt4-T2026-05-28
06009699900947Titamed Spinal SystemHL5S-THL5S-T2026-05-28
06009699900954Titamed Spinal SystemRH60RH602026-05-28
06009699900961Titamed Spinal SystemRH70RH702026-05-28
06009699900978Titamed Spinal SystemRH80RH802026-05-28
06009699900985Titamed Spinal SystemRH90RH902026-05-28
06009699900992Titamed Spinal SystemRH100RH1002026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115932508Tower Guide STPREMIA SPINE LTDNKB2026-07-23
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCNKB2026-07-23
07290115935578PER Trial 60PREMIA SPINE LTDNKB2026-07-22
07290115935691PER Trial 50PREMIA SPINE LTDNKB2026-07-22
00840466901035PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.NKB2026-07-21