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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

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US
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Catalogue (853)

Page 18 of 18
DeviceModel / ReferenceRegistriesClassStatus
ARAI Surgical Navigation System K211254
FDA 510(k)
Class IIActive
HOLO Portal™ Surgical Guidance System K231611
FDA 510(k)
Class IIActive
Cortera Spinal Fixation System K221403
FDA 510(k)
Class IIActive

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