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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
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FDA FEI Number
3009051471
DUNS Number
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Catalogue (6557)

Page 15 of 132
DeviceModel / ReferenceRegistriesClassStatus
VAN GOGH Anterior Cervical Plate System 011.0810
FDA UDI
Class IIActive
Monet ACIF 113.7339
FDA UDI
Class IIActive
Valeo Ii 11.111.5312
FDA UDI
Class IIActive
Picasso Ii 119.7077
FDA UDI
Class IIActive
Picasso 016.3095.L
FDA UDI
Class IIActive
Valeo Ii 11.113.2520
FDA UDI
Class IIActive
Mondrian Alif 120.7730
FDA UDI
Class IIActive
Preference 25-2300-055
FDA UDI
Class IIActive
Matisse 013.1010
FDA UDI
Class IIActive
RAPHAEL Pedicle Screw System 015.3060
FDA UDI
Class IIActive
CEZANNE II Lumbar Interbody Fusion Cage System 018.3310
FDA UDI
Class IIActive
Monet 113.7306
FDA UDI
Class IIActive
Matisse 013.4178B
FDA UDI
Class IIActive
TUBULAR Access 060.7541
FDA UDI
Class IActive
Valeo VBR 030.7115
FDA UDI
Class IIActive
Picasso Ii 019.7015
FDA UDI
Class IActive
RAPHAEL Pedicle Screw System 115.4355
FDA UDI
Class IIActive
Monet ACIF 113.7317
FDA UDI
Class IIActive
Raphael 015.4387
FDA UDI
Class IIActive
Taurus 51-2185-060
FDA UDI
Class IIActive
Mondrian 103.1214
FDA UDI
Class IIActive
Cezanne-Ii 104.6024
FDA UDI
Class IIActive
Matisse Nitro 213.4218
FDA UDI
Class IIActive
CEZANNE Lumbar Interbody Fusion Cage System 017.0612
FDA UDI
Class IIActive
Matisse 013.1310
FDA UDI
Class IIActive
Taurus 50-4000-003
FDA UDI
Class IIActive
Valeo Ii 11.113.6012
FDA UDI
Class IIActive
Matisse 013.1906
FDA UDI
Class IIActive
Monet 113.4509
FDA UDI
Class IIActive
Cezanne 117.2016
FDA UDI
Class IIActive
Valeo Ii 11.016.5815
FDA UDI
Class IIActive
Generic Instruments 100.7081
FDA UDI
Class IActive
VAN GOGH Anterior Cervical Plate System 011.2036
FDA UDI
Class IIActive
MATISSE Anterior Cervical Interbody Fusion Cage System 013.4175
FDA UDI
Class IIActive
Taurus 51-2155-055
FDA UDI
Class IIActive
Mondrian Alif 120.3221
FDA UDI
Class IIActive
Generic 100.6001
FDA UDI
Class IActive
DEGAS Anterior Cervical Plate System 010.1216
FDA UDI
Class IIActive
CEZANNE Lumbar Interbody Fusion Cage System 017.0611
FDA UDI
Class IIActive
Valeo 91.002.2312
FDA UDI
Class IIActive
Mondrian 127.0868
FDA UDI
Class IIActive
CEZANNE II Lumbar Interbody Fusion Cage System 103.7035
FDA UDI
Class IActive
Valeo 11.011.1011
FDA UDI
Class IIActive
Matisse 013.4185B
FDA UDI
Class IIActive
Matisse 013.7780
FDA UDI
Class IIActive
Seurat 126.1546
FDA UDI
Class IIActive
Seurat 126.0951
FDA UDI
Class IIActive
RAPHAEL Pedicle Screw System 015.6030
FDA UDI
Class IIActive
RODIN Expandable Lumbar Cage System 027.7553
FDA UDI
Class IIActive
Cassatt 133.7418
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