FDA.reportPublic FDA data

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

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