OnPoint Spinal Array IN0210201

GUDID 00850051682058

OnPoint Spinal Array

OnPoint Surgical, Inc.

Orthopaedic stereotactic surgery system
Primary Device ID00850051682058
NIH Device Record Key13fc132d-2505-4cdb-baa4-0b0187ae1af0
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnPoint Spinal Array
Version Model Number1
Catalog NumberIN0210201
Company DUNS080659059
Company NameOnPoint Surgical, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com
Phone888-241-2709
Emailsupport@onpointsurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850051682058 [Primary]

FDA Product Code

SBFOrthopedic Augmented Reality

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

[00850051682058]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-14
Device Publish Date2024-10-04

Devices Manufactured by OnPoint Surgical, Inc.

00850051682010 - OnPoint Surgical Cart2024-10-14 OnPoint Surgical Cart (with pre-installed software) - 1 headset
00850051682027 - OnPoint Calibration Block2024-10-14 Calibration phantom
00850051682034 - OnPoint Reusable Instrument Kit #12024-10-14 OnPoint Reusable Instrument Kit #1 with 1 Fixed Adapter, 3 Rotating Adapters, and 2 Power Adapters.
00850051682041 - OnPoint Spine Clamp2024-10-14 OnPoint Spine Clamp
00850051682058 - OnPoint Spinal Array2024-10-14OnPoint Spinal Array
00850051682058 - OnPoint Spinal Array2024-10-14 OnPoint Spinal Array
00850051682065 - OnPoint Pelvic Pin2024-10-14 Pelvic Pin for MIS
00850051682072 - OnPoint Pelvic Pin Adapter2024-10-14 Pelvic Pin Adapter for Spine Array
00850051682089 - OnPoint Pelvic Pin Impactor Cap2024-10-14 Pelvic Pin Impactor Cap
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