FDA.reportPublic FDA data

ONPOINT SURGICAL

Matched from indexed company URL: OnPoint Surgical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165346773016534677ONPOINT SURGICAL1N2026-01-01555 Virginia Rd Suite 103 Concord MA US 01742

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850051682010OnPoint Surgical Cart - OnPoint Surgical Cart (with pre-installed software) - 1 headset888-241-2709support@onpointsurgical.com
00850051682027OnPoint Calibration Block - Calibration phantom888-241-2709support@onpointsurgical.com
00850051682034OnPoint Reusable Instrument Kit #1 - OnPoint Reusable Instrument Kit #1 with 1 Fixed Adapter, 3 Rotating Adapters, and 2 Power Adapters.888-241-2709support@onpointsurgical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3280251519321725K241870OnPoint Augmented Reality Spine SystemSBF2024-08-19
3280251741930989K231284OnPoint Augmented Reality Spine SystemSBF2023-09-08

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
SBF22024-08-19

PMN#

GUDID#