FDA.reportPublic FDA data

CATALYST ORTHOSCIENCE Inc

Matched from indexed company URL: Catalyst Orthoscience, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30125529813012552981CATALYST ORTHOSCIENCE Inc1N2026-01-0114710 Tamiami Trail N., Suite #102 Naples FL US 34110

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
00811596030179CSR Shoulder System - 5.75mm Drill Guide Locking Pin800-587-5137ddavison@catalystortho.com
00811596030193CSR Shoulder System - Small Humeral Cover800-587-5137ddavison@catalystortho.com
00811596030339CSR Shoulder System - XS Angled Reamer800-587-5137ddavison@catalystortho.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1948561355475196K252418Catalyst F1x Shoulder SystemKWS2025-11-06
1948561634220066K234105Catalyst F1x Shoulder SystemPHX2024-04-05
1948561969082096K232583Catalyst R1 Reverse Shoulder SystemPHX2023-09-20
1948561731760248K223655Catalyst R1 Reverse Shoulder SystemPHX2023-05-09
1948561579486494K222317Catalyst EA Convertible Stemmed ShoulderKWS2022-11-10
1948561948138584K213349Catalyst R1 Reverse Shoulder SystemPHX2022-06-23
1948561575785895K211991Catalyst R1 Reverse Shoulder SystemPHX2021-07-28
1948561794543024K202611Catalyst OrthoScience R1 Reverse Shoulder SystemPHX2021-02-12
1948561155838358K191811Catalyst OrthoScience CSR Shoulder SystemKWT2019-09-11
1948561602836347K182500Catalyst CSR Press-Fit Humeral ComponentsKWT2019-01-11
1948561594867341K181287Catalyst CSR Shoulder SystemKWT2018-07-12
1948561318629401K173812Catalyst CSR 3 Peg GlenoidsKWT2018-03-09
1948561518974567K152825Catalyst CSR Shoulder SystemKWT2016-05-11
1948561709352102

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PHX62024-04-05
KWT52019-09-11
KWS22025-11-06

PMN#

GUDID#

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