FDA.reportPublic FDA data

Lead Surgeon Customized AR Headset

Primary DI
00850051682102
Brand
Lead Surgeon Customized AR Headset
Company
OnPoint Surgical, Inc.
Model
1
Catalog number
HA0210101
Device description
Lead Surgeon Customized AR Headset
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBFOrthopedic Augmented RealityNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850051682102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051682102008500516821028500516821020850051682102

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during orthopaedic surgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-241-2709support@onpointsurgical.com

Regulatory Flags#

DUNS number
080659059
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850051682010OnPoint Surgical Cart1NK02101012024-10-04
00850051682027OnPoint Calibration Block1IN02106012024-10-04
00850051682034OnPoint Reusable Instrument Kit #11TK02101012024-10-04
00850051682041OnPoint Spine Clamp1IN02101012024-10-04
00850051682058OnPoint Spinal Array1IN02102012024-10-04
00850051682065OnPoint Pelvic Pin1IN02103012024-10-04
00850051682072OnPoint Pelvic Pin Adapter1IN02104012024-10-04
00850051682089OnPoint Pelvic Pin Impactor Cap1IN02105012024-10-04
00850051682096OnPoint Image Phantom1IN02107012024-10-04
00850051682119OnPoint Hex Driver1IN02108012024-10-04
00850051682126OnPoint Rotating Adapter with Awl Array1IN02114012024-10-04
00850051682133OnPoint Adapter Shaft for Rotating Array1IN02118012024-10-04
00850051682140OnPoint Fixed Adapter with Awl Array1IN02110012024-10-04
00850051682157OnPoint Power Adapter1IN02109012024-10-04
00850051682164OnPoint Rotating Adapter with Tap Array1IN02116012024-10-04
00850051682171OnPoint AR Spine System Reusable Instrument Sterilization Tray1TR02101012024-10-04
00850051682188OnPoint Rotating Adapter with Drill Array1IN02115012024-10-04
00850051682195OnPoint Rotating Adapter with Driver Array1IN02117012024-10-04
00850051682201OnPoint Reusable Instrument Kit #21TK02102012024-10-04
00850051682218AR Headset for Surgeon Assistant1HB02101012024-10-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084604003OptiVu Shoulder Adapter HandleMR Surgical Solutions LLCSBF2026-06-03
00850084604010OptiVu Shoulder Pin InserterMR Surgical Solutions LLCSBF2026-06-03
00850084604027OptiVu Shoulder Cut GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604034OptiVu Shoulder StylusMR Surgical Solutions LLCSBF2026-06-03
00850084604041OptiVu Shoulder Reaming GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604058OptiVu Shoulder Clocking GuideMR Surgical Solutions LLCSBF2026-06-03
00850084604065OptiVu Shoulder Humeral Reference RodMR Surgical Solutions LLCSBF2026-06-03
00850084604072OptiVu Shoulder Scapular Reference RodMR Surgical Solutions LLCSBF2026-06-03
00850084604089OptiVu Shoulder Sterile TrayMR Surgical Solutions LLCSBF2026-06-03
00850084604096OptiVu Shoulder Software ApplicationMR Surgical Solutions LLCSBF2026-06-03
00850084604102OptiVu Shoulder Humeral GaugeMR Surgical Solutions LLCSBF2026-06-03
00850084604119OptiVu Shoulder Tracker KitMR Surgical Solutions LLCSBF2026-06-03
00850084604126OptiVu Shoulder Scapula Anchor PinMR Surgical Solutions LLCSBF2026-06-03
03760297030490KneePlusPIXEE MEDICALSBF2026-05-27
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