FDA.reportPublic FDA data

MONDRIAN Lumbar Interbody Fusion Cage System

Primary DI
00841732132122
Brand
MONDRIAN Lumbar Interbody Fusion Cage System
Company
CTL Medical Corporation
Model
117.2459
Device description
MONDRIAN TLIF Curved Cage, Titanium, 0 Deg, W11xL32, H9mm
Published
2021-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K192863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192863000MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation2020-08-26MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732132122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732132122008417321321228417321321220841732132122

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.

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
00841732162792VALEO91.002.10052024-10-02
00841732151024PREFERENCE Pedicle Screw System10-2900-0452024-09-27
00841732151031PREFERENCE Pedicle Screw System10-2900-0552024-09-27
00841732151048PREFERENCE Pedicle Screw System10-2900-0702024-09-27
00841732151055PREFERENCE Pedicle Screw System10-2900-0902024-09-27
00841732151062PREFERENCE Pedicle Screw System10-2961-5202024-09-27
00841732151079PREFERENCE Pedicle Screw System10-2961-5222024-09-27
00841732151086PREFERENCE Pedicle Screw System10-2961-5242024-09-27
00841732151093PREFERENCE Pedicle Screw System10-2961-5262024-09-27
00841732162761VALEO91.002.10022023-09-30
00841732162778VALEO91.002.10032023-09-30
00841732162785VALEO91.002.10042023-09-30
00841732162686VALEO TL Spacer System91.001.40012023-09-27
00841732162693VALEO TL Spacer System91.001.40022023-09-27
00841732162709GENERIC Surgical Instruments91.001.40052023-09-27
00841732162716GENERIC Surgical Instruments91.001.40152023-09-27
00841732162723VALEO TL Spacer System91.001.40162023-09-27
00841732162730VALEO TL Spacer System91.001.40292023-09-27
00841732162747VALEO TL Spacer System91.001.40382023-09-27
00841732162754GENERIC Surgical Instruments91.001.41152023-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02