HOLO

GUDID 00850028694237

HOLO AR Glasses

Surgalign Spine Technologies, Inc.

Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system

• Primary Device ID: 00850028694237
• NIH Device Record Key: fa87bafe-6f3f-40f2-b317-42fbeb13fa03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOLO
• Version Model Number: 154000053
• Company DUNS: 014520584
• Company Name: Surgalign Spine Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com
• Phone: +1(844)894-7752
• Email: customerservice@surgalign.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850028694237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211254

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-17
• Device Publish Date: 2023-04-07

On-Brand Devices [HOLO]

• 00850028694701: HOLO SL Reduction Driver Lock Tube
• 00850028694688: HOLO Streamline Driver, Lock Tube
• 00850028694671: HOLO Streamline Driver, Open Cannulated
• 00850028694664: HOLO Streamline Driver, Solid
• 00850028694633: HOLO Patient Array
• 00850028694626: HOLO Pin Impact Cap
• 00850028694619: HOLO Iliac Pin, 200mm
• 00850028694602: HOLO Iliac Pin, 150mm
• 00850028694596: HOLO Iliac Pin, 100mm
• 00850028694572: HOLO Streamline Tap, Solid, 9.5 mm
• 00850028694565: HOLO Streamline Tap, Solid, 8.5 mm
• 00850028694558: HOLO Streamline Tap, Solid, 7.5 mm
• 00850028694541: HOLO Streamline Tap, Solid, 6.5 mm
• 00850028694534: HOLO Streamline Tap, Solid, 5.5 mm
• 00850028694527: HOLO Streamline Tap, Solid, 4.5 mm
• 00850028694510: HOLO Streamline Tap, Cann, 9.5 mm
• 00850028694503: HOLO Streamline Tap, Cann, 8.5 mm
• 00850028694497: HOLO Streamline Tap, Cann, 7.5 mm
• 00850028694480: HOLO Streamline Tap, Cann, 6.5 mm
• 00850028694473: HOLO Streamline Tap, Cann, 5.5 mm
• 00850028694466: HOLO Streamline Tap, Cann, 4.5 mm
• 00850028694459: HOLO Streamline Tap, Cann, 4.0 mm
• 00850028694428: HOLO Calibration Tube, Pedicle Prep Ins
• 00850028694237: HOLO AR Glasses
• 00840311242894: HOLO Fixed Handle, 1/4" Square
• 00840311242689: HOLO Calibration Tube, Screwdriver
• 00840311236916: HOLO Probe, Lenke, Iliac, Straight
• 00840311233564: HOLO Probe, Lenke, Thoracic, Straight
• 00840311233557: HOLO Probe, Lenke, Lumbar, Straight
• 00810076560281: HOLO Probe, Lenke, Iliac, Straight
• 00850028694695: HOLO Awl