FDA.reportPublic FDA data

Titamed Spinal System

Primary DI
06009699901685
Brand
Titamed Spinal System
Company
TITAMED (PTY) LTD
Model
PKB10C01
Catalog number
PKB10C01
Device description
Single-use non-sterile implantable barium 10% 4 x 6mm pekk cage 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
06009699901685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06009699901685060096999016856009699901685

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.

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
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-08