CTL Medical Corporation

Carrollton, TX, US

CTL Medical Corporation appears in FDA device records in Carrollton, TX. FDA records list 14 510(k) clearances between 2017-06-01 and 2024-10-10, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 6 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 14
PMA records: 0
Recall records: 6
Registered establishments: 1

510(k) clearance history

FDA records hold 14 510(k) clearances for CTL Medical Corporation between 2017 and 2024. The busiest year on record is 2018, with 4. The most recent is 2024, with 2.

Clearances by year, as a table

510(k) clearance decisions for CTL Medical Corporation, by decision year
Year	Clearances
2017	1
2018	4
2020	1
2022	4
2023	2
2024	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K233947	KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System	MAX	Substantially Equivalent	2024-10-10
K231715	MONDRIAN™ Anterior Lumbar Plate System	KWQ	Substantially Equivalent	2024-01-26
K231359	RODIN™ Expandable Lumbar Cage System	MAX	Substantially Equivalent	2023-06-09
K220513	NITRO Interbody Fusion Cage System Family	ODP	Substantially Equivalent	2023-04-25
K220334	MONET Anterior Cervical Plate System	KWQ	Substantially Equivalent	2022-11-09
K211785	CASSATT™ SIJ Fixation System	OUR	Substantially Equivalent	2022-10-17
K213641	MONDRIAN ALIF Cage with Supplementary Fixation Plate	MAX	Substantially Equivalent	2022-09-15
K213491	Universal Pilot Guidance Instrument System	OLO	Substantially Equivalent	2022-05-12
K192863	MONDRIAN Lumbar Interbody Fusion Cage System	MAX	Substantially Equivalent	2020-08-26
K182151	MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate	OVE	Substantially Equivalent	2018-10-11
K172788	MONET™ Anterior Cervical Interbody Fusion Cage System	ODP	Substantially Equivalent	2018-06-25
K173185	SEURAT™ Universal Pedicle Screw System	NKB	Substantially Equivalent	2018-02-14
K172212	MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™	ODP	Substantially Equivalent	2018-01-09
K162682	MATISSE Anterior Cervical Interbody Fusion Cage System	ODP	Substantially Equivalent	2017-06-01

Registered establishments

FDA registered establishments for CTL Medical Corporation, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3009051471	3009051471	CTL Medical Corporation	2052 McKenzie Drive, Building 1, Carrollton, TX 75006 US	2026	BWN FSM FTY FZX GAD GCY GDG GDI GDZ GFA and 32 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2504-2020	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.	Reports received of the device fracturing during insertion.	Class II	2019-08-21	Completed
Z-2503-2020	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.	Reports received of the device fracturing during insertion.	Class II	2019-08-21	Completed
Z-2502-2020	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.	Reports received of the device fracturing during insertion.	Class II	2019-08-21	Completed
Z-2501-2020	CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.	Reports received of the device fracturing during insertion.	Class II	2019-08-21	Completed
Z-1031-2019	CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050	the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.	Class II	2018-07-05	Terminated
Z-1030-2019	CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050	the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.	Class II	2018-07-05	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain