FDA.reportPublic FDA data

ORTHOFUNDAMENTALS, LLC

Matched from indexed company URL: Orthofundamentals, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30241241723024124172ORTHOFUNDAMENTALS, LLC1N2026-01-0143 Broad St Ste B403 Hudson MA US 01749

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
G204OFSI16OF0Trellis SI Joint Fusion System - 16mm Offset Guide617-398-0317info@orthofundamentals.com
G204OFSI20OF0Trellis SI Joint Fusion System - 20mm Offset Guide617-398-0317info@orthofundamentals.com
G204OFSI24TP0Trellis SI Joint Fusion System - Pack of (3) 2.4mm x 300mm Trocar Point K-Wires617-398-0317info@orthofundamentals.com
G204OFSIALLO0AlloGr8 Posterior Allograft System - Posterior Allograft SI Joint Fusion Instrument Kit617-398-0317info@orthofundamentals.com
G204OFSIANDG0Trellis SI Joint Fusion System - Angled Drill Guide6173062169info@orthofundamentals.com
G204OFSIINST0Trellis SI Joint Fusion System - Lateral SI Joint Fusion Instrument Kit617-398-0317info@orthofundamentals.com
G204OFSIPLIN0Trellis SI Joint Fusion System - Posterolateral SI Joint Fusion Instrument Kit617-398-0317info@orthofundamentals.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3089421136389023K212962TRELLIS™ SI Joint Fusion SystemOUR2022-04-11
3089421603253098

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OUR12022-04-11

PMN#

GUDID#