TOTAL SHOULDER SYSTEM

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

SHOULDER INNOVATIONS, LLC

The following data is part of a premarket notification filed by Shoulder Innovations, Llc with the FDA for Total Shoulder System.

Pre-market Notification Details

• Device ID: K102670
• 510k Number: K102670
• Device Name: TOTAL SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: SHOULDER INNOVATIONS, LLC 4670 FULTON STREET EAST SUITE 202 Ada, MI 49301
• Contact: Andrew Rodenhouse
• Correspondent: Andrew Rodenhouse; SHOULDER INNOVATIONS, LLC 4670 FULTON STREET EAST SUITE 202 Ada, MI 49301
• Product Code: KWS
• Subsequent Product Code: HSD
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-16
• Decision Date: 2011-01-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B1132L2HB00008	K102670	000
B1132L1S0600010	K102670	000
B1132L1S0700010	K102670	000
B1132L1S0800010	K102670	000
B1132L1S0900010	K102670	000
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B1132L1S1100010	K102670	000
B1132L1S1200010	K102670	000
B1132L1S1300010	K102670	000
B1132L1S1400010	K102670	000
B1132L1S1500010	K102670	000
B1132N1BR000280	K102670	000
B1132L1S0500010	K102670	000
B1132L1S0400010	K102670	000
B1132N1HG000000	K102670	000
B1132L2HB00009	K102670	000
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B1132L2HB00011	K102670	000
B1132L2HB00012	K102670	000
B1132L2HB00013	K102670	000
B1132L2HB00014	K102670	000
B1132L2HB00015	K102670	000
B1132L2HI00001	K102670	000
B1132L2HI00002	K102670	000
B1132L2HI00003	K102670	000
B1132N1HE140380	K102670	000
B1132N1HG00000	K102670	000
B1132N1IA000010	K102670	000
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B1132N1IT000000	K102670	000
B1132N1IT100000	K102670	000
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B1132N1KS000010	K102670	000
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B1132N1IN000520	K102670	000
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B1132N1IM000100	K102670	000
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B1130S0SS081300	K102670	000
B1132N1IN000400	K102670	000
B1132N1AC27005	K102670	000
B1132L2HI000110	K102670	000
B1132L2HT000010	K102670	000
B1132R2HC000010	K102670	000
B1132R2HC000020	K102670	000
B1132R2HC000040	K102670	000
B1132N2SN062800	K102670	000
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B1132N2SN063800	K102670	000
B1132N2SN064400	K102670	000
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B1132L2HT000000	K102670	000
B1132L2HS000160	K102670	000
B1132L2HS000140	K102670	000
B1132N1HS000400	K102670	000
B1132N1HS000460	K102670	000
B1132N1HS000520	K102670	000
B1132R2HC000050	K102670	000
B1132R2HC000080	K102670	000
B1132R2HC000090	K102670	000
B1132L2HC000010	K102670	000
B1132L2HS000060	K102670	000
B1132L2HS000080	K102670	000
B1132L2HS000100	K102670	000
B1132L2HS000120	K102670	000
B1132N1AC330100	K102670	000
B1132N1AI330050	K102670	000
B1132L2HB000120	K102670	000
B1132L2HB000130	K102670	000
B1132L2HB000140	K102670	000
B1132L2HB000150	K102670	000
B1132L2HI000010	K102670	000
B1132L2HI000020	K102670	000
B1132L2HI000030	K102670	000
B1130S1GK000020	K102670	000
B1132L2HB00004	K102670	000
B1132L2HB00005	K102670	000
B1132L2HB00006	K102670	000
B1132L2HB000110	K102670	000
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B1132L2HB000090	K102670	000
B1132N1AI330100	K102670	000
B1132N2AI330050	K102670	000
B1132N2AI330100	K102670	000
B1132L2HI000100	K102670	000
B1132N1KS000150	K102670	000
B1132L2HC000000	K102670	000
B1132L2HB000040	K102670	000
B1132L2HB000050	K102670	000
B1132L2HB000060	K102670	000
B1132L2HB000070	K102670	000
B1132L2HB000080	K102670	000
B1132L2HB00007	K102670	000
B1132N1AC27010	K102670	000
B1130S0SS141300	K102670	000
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B1132N1HI000000	K102670	000
B1132N1IA000000	K102670	000
B1132N1ID000000	K102670	000
B1132N1IE000000	K102670	000
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B1132N1IG000000	K102670	000
B1132N1IH000000	K102670	000
B1132N1IJ000000	K102670	000
B1132N1HE210520	K102670	000
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B1132N1HE180560	K102670	000
B1132N1BS000320	K102670	000
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B1132N1HE150400	K102670	000
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B1132N1IM000000	K102670	000
B1132N1IP000400	K102670	000
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B1132N2HE180441	K102670	000
B1132N2HE180481	K102670	000
B1132N2HE180521	K102670	000
B1132N2HE180561	K102670	000
B1132N2HE210441	K102670	000
B1132N2HE210481	K102670	000
B1132N2HE210521	K102670	000
B1132N2HE210561	K102670	000
B1132N2SN063201	K102670	000
B1132N2SN063801	K102670	000
B1132N2HE150521	K102670	000
B1132N2HE150481	K102670	000
B1132N2HE150441	K102670	000
B1132N1IP000440	K102670	000
B1132N1IP000480	K102670	000
B1132N1IP000520	K102670	000
B1132N1IP000560	K102670	000
B1132N1IR00000	K102670	000
B1132N1IS000010	K102670	000
B1132N1IV000000	K102670	000
B1132N1IZ000400	K102670	000
B1132N1IZ000480	K102670	000
B1132N1IZ000520	K102670	000
B1132N2HE150401	K102670	000
B1132N2SN064401	K102670	000
B1132N1AC30005	K102670	000
B1132N2HE210500	K102670	000
B1132N1AI220050	K102670	000
B1132N1AI220100	K102670	000
B1132N1AI240050	K102670	000
B1132N1AI240100	K102670	000
B1132N1AI270050	K102670	000
B1132N1AI270100	K102670	000
B1132N1AI300050	K102670	000
B1132N1AI300100	K102670	000
B1132N2AI220100	K102670	000
B1132N2AI240050	K102670	000
B1132N2HE200520	K102670	000
B1132N2HE190500	K102670	000
B1132N2HE180460	K102670	000
B1132N1AC30010	K102670	000
B1132N1BS000280	K102670	000
B1132N1HE160420	K102670	000
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B1132N1HE200520	K102670	000
B1132N1HE210500	K102670	000
B1132N1IV000060	K102670	000
B1132N2HE160420	K102670	000
B1132N2HE170440	K102670	000
B1132N2AI240100	K102670	000
B1132N2AI270050	K102670	000
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B1130S0SS061300	K102670	000
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B1130S0HO150400	K102670	000
B1130S0CI300080	K102670	000
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B1132N2AI270100	K102670	000
B1132N2AI300050	K102670	000
B1132N2AI300100	K102670	000
B1132N2AI220050	K102670	000
B1132N1IC000000	K102670	000
B1130S0CI220060	K102670	000
B1130S0CI220080	K102670	000
B1130S0CI240060	K102670	000
B1130S0CI240080	K102670	000
B1130S0CI270060	K102670	000
B1130S0CI270080	K102670	000
B1130S0SS121300	K102670	000