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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
—
EUDAMED SRN
—
FDA FEI Number
3009051471
DUNS Number
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Catalogue (6557)

Page 9 of 132
DeviceModel / ReferenceRegistriesClassStatus
Taurus 51-2185-055
FDA UDI
Class IIActive
Cezanne-Ii 104.7031
FDA UDI
Class IIActive
PICASSO II MIS Spinal System 019.1556
FDA UDI
Class IIActive
Klimt 367.7013
FDA UDI
Class IIActive
CEZANNE II Lumbar Interbody Fusion Cage System 018.3613
FDA UDI
Class IIActive
Preference 25-8200-060
FDA UDI
Class IIActive
Valeo Ii 042.7258
FDA UDI
Class IIActive
Monet 113.5105
FDA UDI
Class IIActive
VAN GOGH Anterior Cervical Plate System 011.0832
FDA UDI
Class IIActive
Taurus 25-2000-060
FDA UDI
Class IIActive
CEZANNE Lumbar Interbody Fusion Cage System 017.1113
FDA UDI
Class IIActive
Matisse 013.7612
FDA UDI
Class IIActive
RAPHAEL Pedicle Screw System 115.7033
FDA UDI
Class IActive
RAPHAEL Pedicle Screw System 115.3435
FDA UDI
Class IIActive
Raphael 015.3952
FDA UDI
Class IIActive
RAPHAEL Pedicle Screw System 015.8700
FDA UDI
Class IActive
Preference 25-8200-080
FDA UDI
Class IIActive
Rodin S.027.1021
FDA UDI
Class IIActive
TUBULAR Access 060.6042
FDA UDI
Class IActive
Raphael 015.4362
FDA UDI
Class IIActive
Generic 060.8710
FDA UDI
Class IActive
RAPHAEL Pedicle Screw System 115.1660
FDA UDI
Class IIActive
Mondrian Alif 120.8020
FDA UDI
Class IIActive
Picasso 016.6155
FDA UDI
Class IIActive
CEZANNE II Lumbar Interbody Fusion Cage System 103.7252
FDA UDI
Class IActive
Seurat 126.0446
FDA UDI
Class IIActive
Raphael 015.4332
FDA UDI
Class IIActive
CEZANNE II Lumbar Interbody Fusion Cage System 103.0009
FDA UDI
Class IActive
CEZANNE II Lumbar Interbody Fusion Cage System 018.4116
FDA UDI
Class IIActive
Valeo Ii 12.600.1609
FDA UDI
Class IIActive
RAPHAEL Pedicle Screw System 015.8120
FDA UDI
Class IActive
MATISSE Anterior Cervical Interbody Fusion Cage System 013.7510
FDA UDI
Class IActive
Monet 113.7429
FDA UDI
Class IIActive
Navigation 109.7835
FDA UDI
Class IIActive
Mondrian 103.1235
FDA UDI
Class IIActive
Mondrian Alif 106.7269
FDA UDI
Class IIActive
Van Gogh 011.0434
FDA UDI
Class IIActive
RODIN Expandable Lumbar Cage System 027.7222
FDA UDI
Class IIActive
Raphael 015.4547
FDA UDI
Class IIActive
RAPHAEL Pedicle Screw System 115.0255
FDA UDI
Class IIActive
RAPHAEL Pedicle Screw System 115.5355
FDA UDI
Class IIActive
Monet 113.0814
FDA UDI
Class IIActive
Generic 060.7494
FDA UDI
Class IActive
Matisse 013.7502
FDA UDI
Class IIActive
Generic 100.6004
FDA UDI
Class IActive
RENOIR Posterior Cervico-Thoracic Fixation System 012.1040
FDA UDI
Class IIActive
VAN GOGH Anterior Cervical Plate System 011.2024
FDA UDI
Class IIActive
Mondrian Alif 106.7006
FDA UDI
Class IIActive
RAPHAEL Pedicle Screw System 015.5145
FDA UDI
Class IIActive
Taurus 51-3055-050
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