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Surgalign Spine Technologies

US

Last updated May 23, 2026

What Surgalign Spine Technologies makes

Surgalign Spine Technologies makes bone-screw internal spinal fixation systems, bone taps, abdominal/ENT/orthopaedic surgical probes, surgical screwdrivers, multi-purpose stereotactic surgery systems, orthopaedic bone pins, optical surgical navigation device tracking systems, and bone matrix implants derived from human tissue.

The company's devices are classified as Class I and Class II and are listed in the FDA's Unique Device Identification (fda_udi) registry. Surgalign Spine Technologies is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of devices does Surgalign Spine Technologies manufacture?

Surgalign Spine Technologies manufactures bone-screw internal spinal fixation systems, bone taps, abdominal/ENT/orthopaedic surgical probes, surgical screwdrivers, multi-purpose stereotactic surgery systems, orthopaedic bone pins, optical surgical navigation device tracking systems, and bone matrix implants derived from human tissue. These are the device categories explicitly listed in the provided data, and no other products or functions are attributed to the company in this source.

Where is Surgalign Spine Technologies based?

Surgalign Spine Technologies is based in the United States, as stated directly in the SUMMARY section of the device data. The company's country of origin is explicitly listed as US, and no other location or operational details are provided or implied in the source material.

In which regulatory registry are Surgalign Spine Technologies' devices listed?

Surgalign Spine Technologies' devices are listed in the FDA's Unique Device Identification (fda_udi) registry, as specified in the LISTED IN field and reiterated in the SUMMARY. This is the only registry mentioned in the data, and no other national or international registries are referenced for this company's devices.

How are Surgalign Spine Technologies' devices classified under regulatory frameworks?

Surgalign Spine Technologies' devices are classified as Class I and Class II, as indicated in the DEVICE CLASSES field and confirmed in the SUMMARY. This classification reflects the risk-based categorization used by the FDA, and the data does not assign any devices to Class III or suggest any devices are unclassified or exempt from classification.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
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EUDAMED SRN
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FDA FEI Number
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Catalogue (853)

Page 11 of 18
DeviceModel / ReferenceRegistriesClassStatus
Cortera 150150-70090
FDA UDI
Class IIActive
Cortera 1505-800280
FDA UDI
Class IIActive
Cortera 150100-20120
FDA UDI
Class IIActive
Cortera 150100-15075
FDA UDI
Class IIActive
Cortera 150100-20095
FDA UDI
Class IIActive
Cortera 150100-95070
FDA UDI
Class IIActive
Cortera 150100-60100
FDA UDI
Class IIActive
Cortera 150100-55090
FDA UDI
Class IIActive
Cortera 150150-60100
FDA UDI
Class IIActive
Cortera 150152-70085
FDA UDI
Class IIActive
Cortera 150103-50095
FDA UDI
Class IIActive
Cortera 150150-60080
FDA UDI
Class IIActive
Cortera 150100-85095
FDA UDI
Class IIActive
Fortilink 65-TC-INSERTER
FDA UDI
Class IIActive
Cortera 1505-812800
FDA UDI
Class IIActive
Cortera 150150-75085
FDA UDI
Class IIActive
Cortera 150150-20085
FDA UDI
Class IIActive
Cortera 150100-80070
FDA UDI
Class IIActive
Cortera 150152-80115
FDA UDI
Class IIActive
Cortera 150103-75120
FDA UDI
Class IIActive
Cortera 150150-50120
FDA UDI
Class IIActive
Cortera 1505-811050
FDA UDI
Class IIActive
Cortera 150100-10070
FDA UDI
Class IIActive
Cortera 150103-80090
FDA UDI
Class IIActive
Cortera 150103-85070
FDA UDI
Class IIActive
Cortera 150100-10120
FDA UDI
Class IIActive
BiomaX BMX-0110
FDA UDI
Class IIActive
Cortera 150100-90090
FDA UDI
Class IIActive
Cortera 150103-65090
FDA UDI
Class IIActive
Holo 154000053
FDA UDI
Class IIActive
Cortera 150150-95070
FDA UDI
Class IIActive
Cortera 1505-850950
FDA UDI
Class IIActive
Cortera 150100-10090
FDA UDI
Class IIActive
Cortera 150150-80085
FDA UDI
Class IIActive
Cortera 150152-90070
FDA UDI
Class IIActive
Cortera 150150-65115
FDA UDI
Class IIActive
Streamline 02-SCREWINS-CL-MDN
FDA UDI
Class IIActive
Holo 155000001
FDA UDI
Class IActive
Cortera 150150-50110
FDA UDI
Class IIActive
Cortera 150150-60065
FDA UDI
Class IIActive
Cortera 150100-60115
FDA UDI
Class IIActive
Cortera 150150-00115
FDA UDI
Class IIActive
Cortera 150150-05070
FDA UDI
Class IIActive
Cortera 150100-10110
FDA UDI
Class IIActive
Cortera 1505-811150
FDA UDI
Class IIActive
Cortera 150100-95075
FDA UDI
Class IIActive
Cortera 150100-50085
FDA UDI
Class IIActive
Cortera 150100-70110
FDA UDI
Class IIActive
Cortera 150103-60105
FDA UDI
Class IIActive
Cortera 150100-05070
FDA UDI
Class IIActive

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