FDA.reportPublic FDA data

KLIMT Expandable Lumbar Interbody Fusion Cage System

Primary DI
00841732167810
Brand
KLIMT Expandable Lumbar Interbody Fusion Cage System
Company
CTL Medical Corporation
Model
367.7510
Device description
Driver, T10
Published
2025-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233947000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233947000KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation2024-10-10MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732167810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732167810008417321678108417321678100841732167810

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
214-545-5820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841732168091MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87002026-08-14
00841732168107MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87042026-08-14
00841732168114MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87012026-08-14
00841732168121MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87022026-08-14
00841732168138MONDRIAN ALIF Cage with Supplementary Fixation Plate120.87032026-08-14
00841732168527TAURUS Pedicle Screw System059.80132026-07-28
00841732169272PICASSO MIS Spinal System016.31602026-07-24
00841732169289PICASSO MIS Spinal System016.31702026-07-24
00841732169296PICASSO MIS Spinal System016.31802026-07-24
00841732169302PICASSO MIS Spinal System016.31902026-07-24
00841732169319PICASSO MIS Spinal System016.32002026-07-24
00841732163447VALEO C Spacer System91.002.40012023-09-30
00841732163454VALEO C Spacer System91.002.40022023-09-30
00841732163461VALEO C Spacer System91.002.40032023-09-30
00841732128231VALEO VBR91.009.56512023-09-27
00841732128248VALEO VBR91.009.56522023-09-27
00841732145511VALEO C+CSC with Lumen Interbody Fusion Device11.209.17072023-09-19
00841732145528VALEO C+CSC with Lumen Interbody Fusion Device11.209.17082023-09-19
00841732145535VALEO C+CSC with Lumen Interbody Fusion Device11.209.17092023-09-19
00841732145542VALEO C+CSC with Lumen Interbody Fusion Device11.209.17102023-09-19

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Primary DI, Brand, Company table
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