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CTL Medical Corporation

US

Last updated September 17, 2026

Information

Country
US
Address
2052 McKenzie Drive, Building 1, Carrollton, TX, 75006
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
3009051471
DUNS Number
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Catalogue (6557)

Page 7 of 132
DeviceModel / ReferenceRegistriesClassStatus
VAN GOGH Anterior Cervical Plate System 011.5089
FDA UDI
Class IIActive
Valeo Ii 11.016.6410
FDA UDI
Class IIActive
DEGAS Anterior Cervical Plate System 010.1518
FDA UDI
Class IIActive
Cezanne 017.0074
FDA UDI
Class IIActive
RAPHAEL Pedicle Screw System 015.7764
FDA UDI
Class IActive
MATISSE Anterior Cervical Interbody Fusion Cage System 013.7549
FDA UDI
Class IActive
Monet 113.0816
FDA UDI
Class IIActive
Valeo Ii 11.020.5416
FDA UDI
Class IIActive
TUBULAR Access 060.7303
FDA UDI
Class IActive
PICASSO II MIS Spinal System 019.7033
FDA UDI
Class IActive
VAN GOGH Anterior Cervical Plate System 011.2028
FDA UDI
Class IIActive
VAN GOGH Anterior Cervical Plate System 011.7154
FDA UDI
Class IActive
Cezanne 017.0111
FDA UDI
Class IIActive
TUBULAR Access 060.6020
FDA UDI
Class IActive
Matisse 013.4806
FDA UDI
Class IIActive
Monet 113.4405
FDA UDI
Class IIActive
Taurus 059.7056.D
FDA UDI
Class IIActive
Seurat 126.2844
FDA UDI
Class IIActive
Cezanne-Ii 104.6264
FDA UDI
Class IIActive
CEZANNE Lumbar Interbody Fusion Cage System 017.0709
FDA UDI
Class IIActive
Seurat 126.2391
FDA UDI
Class IIActive
Valeo 91.001.1012
FDA UDI
Class IIActive
Matisse 013.4216B
FDA UDI
Class IIActive
Dali 014.0281
FDA UDI
Class IIActive
Cezanne 117.1607
FDA UDI
Class IIActive
Valeo Ii 12.400.1009
FDA UDI
Class IIActive
Mondrian 127.0833
FDA UDI
Class IIActive
Seurat 126.2799
FDA UDI
Class IIActive
Valeo 11.002.2608
FDA UDI
Class IIActive
Seurat 126.2621
FDA UDI
Class IIActive
Seurat 126.2141
FDA UDI
Class IIActive
TUBULAR Access 060.7481
FDA UDI
Class IActive
Mondrian 117.2723
FDA UDI
Class IIActive
RODIN Expandable Lumbar Cage System 027.7601
FDA UDI
Class IIActive
Monet 213.7332
FDA UDI
Class IIActive
MATISSE Anterior Cervical Interbody Fusion Cage System 013.4135
FDA UDI
Class IIActive
Matisse 013.4122
FDA UDI
Class IIActive
Valeo C+csc 11.209.1105
FDA UDI
Class IIActive
CEZANNE II Lumbar Interbody Fusion Cage System 018.3913
FDA UDI
Class IIActive
Valeo 11.009.2619
FDA UDI
Class IIActive
CEZANNE II Lumbar Interbody Fusion Cage System 018.4811
FDA UDI
Class IIActive
Taurus 51-2055-025
FDA UDI
Class IIActive
Matisse 013.4179B
FDA UDI
Class IIActive
Picasso Ii 129. 0555
FDA UDI
Class IIActive
Valeo Ii 11.016.4411
FDA UDI
Class IIActive
Taurus 25-2002-035
FDA UDI
Class IIActive
Valeo Ii 11.020.3810
FDA UDI
Class IIActive
Taurus 25-2201-600
FDA UDI
Class IIActive
Monet 113.4105
FDA UDI
Class IIActive
Valeo Ii 11.111.2715
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (6)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Aug 21, 2019Z-2501-2020—completed

Reports received of the device fracturing during insertion.

Aug 21, 2019Z-2504-2020—completed

Reports received of the device fracturing during insertion.

Aug 21, 2019Z-2503-2020—completed

Reports received of the device fracturing during insertion.

Aug 21, 2019Z-2502-2020—completed

Reports received of the device fracturing during insertion.

Jul 5, 2018Z-1031-2019—terminated

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.

Jul 5, 2018Z-1030-2019—terminated

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.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Hh Medical Co., Ltd. Ansan Gyeonggi · KR FEI 3038184658