Shoulder Innovations Inc

FDA Filings

This page includes the latest FDA filings for Shoulder Innovations Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012544635
• FEI Number: 3012544635
• Name: SHOULDER INNOVATIONS, Inc
• Owner & Operator: Shoulder Innovations, Inc
• Contact Address: 13827 Port Sheldon Street ; Holland MI 49424 US
• Official Correspondent:
  • Matthew Ahearn
  • 001-616-2941026-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 13827 Port Sheldon St ; Holland, MI 49424 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID B1132L2HS700050 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L2HS70005	2025-09-26
GUDID B1132L2HS700040 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L2HS70004	2025-09-26
GUDID B1132L2HG700380 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L2HG70038	2025-09-26
GUDID B1130S1GK000030 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 0S1GK00003	2025-09-26
GUDID B1132L2HC000040 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2L2HC00004	2025-09-22
GUDID B1132L2HI000040 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L2HI00004	2025-06-06
GUDID B1132L1S1400000 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L1S140000	2025-06-06
GUDID B1132L1S1200000 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L1S120000	2025-06-06
GUDID B1132L1S1000000 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L1S100000	2025-06-06
GUDID B1132L1S0800000 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L1S080000	2025-06-06
GUDID B1132L1S0600000 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L1S060000	2025-06-06
GUDID B1132L1S0400000 Shoulder Innovations, Inc.	Shoulder Innovations InSet 70 Humeral Stem 2L1S040000	2025-06-06
GUDID B1132L2HI000110 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HI00011	2025-05-20
GUDID B1132R2HC000090 Shoulder Innovations, Inc.	Shoulder Innovations IM Cut Guide 2R2HC00009	2025-04-28
GUDID B1132R2HC000080 Shoulder Innovations, Inc.	Shoulder Innovations IM Cut Guide 2R2HC00008	2025-04-28
GUDID B1132R2HC000050 Shoulder Innovations, Inc.	Shoulder Innovations IM Cut Guide 2R2HC00005	2025-04-28
GUDID B1132N1HS000520 Shoulder Innovations, Inc.	Shoulder Innovations TSA 2N1HS00052	2025-04-28
GUDID B1132N1HS000460 Shoulder Innovations, Inc.	Shoulder Innovations TSA 2N1HS00046	2025-04-28
GUDID B1132N1HS000400 Shoulder Innovations, Inc.	Shoulder Innovations TSA 2N1HS00040	2025-04-28
GUDID B1132R1Y2415150 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R1Y241515	2025-03-17
GUDID B1132R1Y2410150 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R1Y241015	2025-03-17
GUDID B1132R1Y2405150 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R1Y240515	2025-03-17
GUDID B1132R1Y2400150 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R1Y240015	2025-03-17
GUDID B1132L2HT000010 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HT00001	2024-09-09
GUDID B1132L2HT000000 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HT00000	2024-09-09
GUDID B1132L2HS000160 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HS00016	2024-09-09
GUDID B1132L2HS000140 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HS00014	2024-09-09
GUDID B1132L2HS000120 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HS00012	2024-09-09
GUDID B1132L2HS000100 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HS00010	2024-09-09
GUDID B1132L2HS000080 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HS00008	2024-09-09
GUDID B1132L2HS000060 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HS00006	2024-09-09
GUDID B1132L2HC000010 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HC00001	2024-09-09
GUDID B1132R2HI001100 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2HI00110	2024-07-03
GUDID B1132R2HI001050 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2HI00105	2024-07-03
GUDID B1132R2HC000040 Shoulder Innovations, Inc.	Shoulder Innovations IM Cut Guide 2R2HC00004	2024-06-17
GUDID B1132R2HC000020 Shoulder Innovations, Inc.	Shoulder Innovations IM Cut Guide 2R2HC00002	2024-06-17
GUDID B1132R2HC000010 Shoulder Innovations, Inc.	Shoulder Innovations IM Cut Guide 2R2HC00001	2024-06-17
GUDID B1132N2SN064400 Shoulder Innovations, Inc.	Shoulder Innovations Humeral Short Stem System 2N2SN06440	2024-05-15
GUDID B1132N2SN063800 Shoulder Innovations, Inc.	Shoulder Innovations Humeral Short Stem System 2N2SN06380	2024-05-15
GUDID B1132N2SN063200 Shoulder Innovations, Inc.	Shoulder Innovations Humeral Short Stem System 2N2SN06320	2024-05-15
GUDID B1132N2SN062800 Shoulder Innovations, Inc.	Shoulder Innovations Humeral Short Stem System 2N2SN06280	2024-05-15
GUDID B1132R2HP000480 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2HP00048	2024-05-08
GUDID B1132R2HP000440 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2HP00044	2024-05-08
GUDID B1132R2HP000400 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2HP00040	2024-05-08
GUDID B1132R2GK000000 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2GK00000	2024-05-08
GUDID B1132N2AI330100 Shoulder Innovations, Inc.	Shoulder Innovations TSA 2N2AI33010	2024-05-06
GUDID B1132N2AI330050 Shoulder Innovations, Inc.	Shoulder Innovations TSA 2N2AI33005	2024-05-06
GUDID B1132N1AI330100 Shoulder Innovations, Inc.	Shoulder Innovations TSA 2N1AI33010	2024-05-06
GUDID B1132N1AI330050 Shoulder Innovations, Inc.	Shoulder Innovations TSA 2N1AI33005	2024-05-06
GUDID B1132N1AC330100 Shoulder Innovations, Inc.	Shoulder Innovations TSA 2N1AC33010	2024-05-06
GUDID B1132N1AC330050 Shoulder Innovations, Inc.	Shoulder Innovations TSA 2N1AC33005	2024-05-06
GUDID B1130S0CI330080 Shoulder Innovations, Inc.	Shoulder Innovations TSA 0S0CI33008	2024-05-06
GUDID B1130S0CI330060 Shoulder Innovations, Inc.	Shoulder Innovations TSA 0S0CI33006	2024-05-06
GUDID B1132R1GLC06330 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R1GLC0633	2024-04-09
GUDID B1132N1KS000150 Shoulder Innovations, Inc.	Shoulder Innovations TSA	2024-03-05
GUDID B1132L2HI000100 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem	2024-03-05
GUDID B1132N1AT000030 Shoulder Innovations, Inc.	SHOULDER INNOVATIONS TSA SYSTEM 2N1AT00003	2023-12-25
GUDID B1132L2HC000000 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HC00000	2023-12-15
GUDID B1132L2HI000030 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HI00003	2023-12-07
GUDID B1132L2HI000020 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HI00002	2023-12-07
GUDID B1132L2HI000010 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HI00001	2023-12-07
GUDID B1132L2HB000150 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00015	2023-12-07
GUDID B1132L2HB000140 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00014	2023-12-07
GUDID B1132L2HB000130 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00013	2023-12-07
GUDID B1132L2HB000120 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00012	2023-12-07
GUDID B1132L2HB000110 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00011	2023-12-07
GUDID B1132L2HB000100 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00010	2023-12-07
GUDID B1132L2HB000090 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00009	2023-12-07
GUDID B1132L2HB000080 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00008	2023-12-07
GUDID B1132L2HB000070 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00007	2023-12-07
GUDID B1132L2HB000060 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00006	2023-12-07
GUDID B1132L2HB000050 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00005	2023-12-07
GUDID B1132L2HB000040 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00004	2023-12-07
GUDID B1130S1GK000020 Shoulder Innovations, Inc.	Shoulder Innovations Humeral Short Stem System 0S1GK00002	2023-12-06
GUDID B1132L2HI00003 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HI00003	2023-11-10
GUDID B1132L2HI00002 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HI00002	2023-11-10
GUDID B1132L2HI00001 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HI00001	2023-11-10
GUDID B1132L2HB00015 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00015	2023-11-10
GUDID B1132L2HB00014 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00014	2023-11-10
GUDID B1132L2HB00013 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00013	2023-11-10
GUDID B1132L2HB00012 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00012	2023-11-10
GUDID B1132L2HB00011 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00011	2023-11-10
GUDID B1132L2HB00010 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00010	2023-11-10
GUDID B1132L2HB00009 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00009	2023-11-10
GUDID B1132L2HB00008 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00008	2023-11-10
GUDID B1132L2HB00007 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00007	2023-11-10
GUDID B1132L2HB00006 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00006	2023-11-10
GUDID B1132L2HB00005 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00005	2023-11-10
GUDID B1132L2HB00004 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L2HB00004	2023-11-10
GUDID B1132R2GT500000 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2GT50000	2023-10-31
GUDID B1132R2HI000430 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2HI00043	2023-10-27
GUDID B1132R2HI000400 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2HI00040	2023-10-27
GUDID B1132R2GR539240 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2GR53924	2023-10-18
GUDID B1132R2GR536240 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2GR53624	2023-10-18
GUDID B1132R2GR533240 Shoulder Innovations, Inc.	Shoulder Innovations Inset Reverse Total Shoulder 2R2GR53324	2023-10-18
GUDID B1132N1HG000000 Shoulder Innovations, Inc.	Shoulder Innovations Humeral Short Stem System 2N1HG00000	2023-10-18
GUDID B1132N1HE140380 Shoulder Innovations, Inc.	Shoulder Innovations Humeral Short Stem System 2N1HE14038	2023-10-18
GUDID B1132L1S0600010 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L1S060001	2023-10-11
GUDID B1132L1S0500010 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L1S050001	2023-10-11
GUDID B1132L1S0400010 Shoulder Innovations, Inc.	Shoulder Innovations InSet 95 Humeral Stem 2L1S040001	2023-10-11
PMN K213615 Shoulder Innovations, Inc.	Shoulder Innovations Total Shoulder System	2022-03-11
PMN K210533 Shoulder Innovations, Inc.	Inset Reverse Total Shoulder System	2021-08-20
PMN K192365 Shoulder Innovations Inc	Shoulder Innovations Total Shoulder System	2019-11-29
PMN K173824 | MBF SHOULDER INNOVATIONS, Inc	Humeral Short Stem System	2018-12-05
PMN K173824 | KWT SHOULDER INNOVATIONS, Inc	Humeral Short Stem System	2018-12-05
PMN K173824 | KWS SHOULDER INNOVATIONS, Inc	Humeral Short Stem System	2018-12-05
PMN K173824 | HSD SHOULDER INNOVATIONS, Inc	Humeral Short Stem System	2018-12-05
PMN K173824 Shoulder Innovations Inc	Humeral Short Stem System	2018-10-23
PMN K111596 | KWT SHOULDER INNOVATIONS, Inc	Shoulder Innovations Total Shoulder Replacement System	2016-05-26
PMN K111596 | KWS SHOULDER INNOVATIONS, Inc	Shoulder Innovations Total Shoulder Replacement System	2016-05-26
PMN K111596 | HSD SHOULDER INNOVATIONS, Inc	Shoulder Innovations Total Shoulder Replacement System	2016-05-26
PMN K110905 | KWT SHOULDER INNOVATIONS, Inc	Shoulder Innovations Total Shoulder Replacement System	2016-05-26
PMN K110905 | KWS SHOULDER INNOVATIONS, Inc	Shoulder Innovations Total Shoulder Replacement System	2016-05-26
PMN K110905 | HSD SHOULDER INNOVATIONS, Inc	Shoulder Innovations Total Shoulder Replacement System	2016-05-26
PMN K102670 | KWT SHOULDER INNOVATIONS, Inc	Shoulder Innovations Total Shoulder Replacement System	2016-05-26
PMN K102670 | KWS SHOULDER INNOVATIONS, Inc	Shoulder Innovations Total Shoulder Replacement System	2016-05-26
PMN K102670 | HSD SHOULDER INNOVATIONS, Inc	Shoulder Innovations Total Shoulder Replacement System	2016-05-26

Related Finance Registrations

SEC

0001699350

SHOULDER INNOVATIONS, INC. of MI