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 B1132L2HS00005 Shoulder Innovations, Inc.	Shoulder Innovations InSet Slap Hammer Base 2L2HS00005	2025-12-22
GUDID B1132L2HS000040 Shoulder Innovations, Inc.	Shoulder Innovations InSet Slap Hammer Weight 2L2HS00004	2025-12-22
GUDID B1132L2HS000030 Shoulder Innovations, Inc.	Shoulder Innovations InSet Slap Hammer Threaded Nut 2L2HS00003	2025-12-22
GUDID B1132L2HS000020 Shoulder Innovations, Inc.	Shoulder Innovations InSet Slap Hammer Rod 2L2HS00002	2025-12-22
GUDID B1132L2HR185140 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 Combination Reamer 2L2HR18514	2025-12-22
GUDID B1132L2HR185120 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 Combination Reamer 2L2HR18512	2025-12-22
GUDID B1132L2HR185100 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 Combination Reamer 2L2HR18510	2025-12-22
GUDID B1132L2HR185080 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 Combination Reamer 2L2HR18508	2025-12-22
GUDID B1132L2HR185060 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 Combination Reamer 2L2HR18506	2025-12-22
GUDID B1132L2HR135140 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Combination Reamer 2L2HR13514	2025-12-22
GUDID B1132L2HR135120 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Combination Reamer 2L2HR13512	2025-12-22
GUDID B1132L2HR135100 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Combination Reamer 2L2HR13510	2025-12-22
GUDID B1132L2HR135080 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Combination Reamer 2L2HR13508	2025-12-22
GUDID B1132L2HR135060 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Combination Reamer 2L2HR13506	2025-12-22
GUDID B1132L2HR135040 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Combination Reamer 2L2HR13504	2025-12-22
GUDID B1132L2HI185010 Shoulder Innovations, Inc.	Shoulder Innovations InSet 185 Impaction Stand Tower 2L2HI18501	2025-12-22
GUDID B1132L2HI135030 Shoulder Innovations, Inc.	Shoulder Innovations InSet 135/185 Adjustable Foot 2L2HI13503	2025-12-22
GUDID B1132L2HI135020 Shoulder Innovations, Inc.	Shoulder Innovations InSet 135/185 Impaction Stand Base 2L2HI13502	2025-12-22
GUDID B1132L2HI135010 Shoulder Innovations, Inc.	Shoulder Innovations InSet 135 Impaction Stand Tower 2L2HI13501	2025-12-22
GUDID B1132L2HB285120 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 Humeral Stem Trial 2L2HB28512	2025-12-22
GUDID B1132L2HB285100 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 Humeral Stem Trial 2L2HB28510	2025-12-22
GUDID B1132L2HB285080 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 Humeral Stem Trial 2L2HB28508	2025-12-22
GUDID B1132L2HB285060 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 Humeral Stem Trial 2L2HB28506	2025-12-22
GUDID B1132L2HB235120 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Humeral Stem Trial 2L2HB23512	2025-12-22
GUDID B1132L2HB235100 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Humeral Stem Trial 2L2HB23510	2025-12-22
GUDID B1132L2HB235080 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Humeral Stem Trial 2L2HB23508	2025-12-22
GUDID B1132L2HB235060 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Humeral Stem Trial 2L2HB23506	2025-12-22
GUDID B1132L2HB235040 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 Humeral Stem Trial 2L2HB23504	2025-12-22
GUDID B1132L2HB000030 Shoulder Innovations, Inc.	Shoulder Innovations InSet 185 Instrument Case/Tray 2L2HB00003	2025-12-22
GUDID B1132L2HB000020 Shoulder Innovations, Inc.	Shoulder Innovations InSet 135 Instrument Case/Tray 2L2HB00002	2025-12-22
GUDID B1132L1S1200030 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 2L1S120003	2025-12-22
GUDID B1132L1S1200020 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 2L1S120002	2025-12-22
GUDID B1132L1S1000030 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 2L1S100003	2025-12-22
GUDID B1132L1S1000020 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 2L1S100002	2025-12-22
GUDID B1132L1S0800030 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 2L1S080003	2025-12-22
GUDID B1132L1S0800020 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 2L1S080002	2025-12-22
GUDID B1132L1S0600030 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 185 2L1S060003	2025-12-22
GUDID B1132L1S0600020 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 2L1S060002	2025-12-22
GUDID B1132L1S0400020 Shoulder Innovations, Inc.	Shoulder Innovations InSet FxR 135 2L1S040002	2025-12-22
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 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
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