InSet Total Shoulder System
Shoulder Innovations, Inc. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Grand Rapids
- Advisory committee description
- Orthopedic
- Address 1
- 1535 Steele Ave. SW
- Address 2
- Suite B
- Statement or summary
- Summary
- Product code
- KWT
- Zip code
- 49507
- Applicant
- Shoulder Innovations, Inc.
- Decision date
- 2025-02-11
- Decision code
- SESE
- Country code
- US
- Device name
- InSet Total Shoulder System
- Advisory committee
- OR
- Contact
- Mark Hanes
- K number
- K241817
- State
- MI
- Date received
- 2024-06-24
- Review advisory committee
- OR
- Postal code
- 49507
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3650
- Device class
- 2
- Registration number
- 3008868758, 1822565, 1057425, 8043792, 3014302784, 3010287737, 1226544, 3006356043, 1835572, 3002806603, 3006801265, 3010047402, 3007051929, 3013194153, 3005180920, 2244478, 3007993775, 1644408, 3009887475, 3010065126, 9613350, 3004976965, 3012552981, 3008395353, 3009871135, 3006085220, 3008812560, 3006017180, 3033509898, 3006984710, 3010057495, 3006563559, 3007740680, 3017397663, 3011189525, 1833986, 3010009693, 3010375065, 9611390, 3010370880 +114 more
- FEI number
- 3008868758, 3014302784, 3010287737, 3006356043, 3002807036, 3002806603, 3006801265, 3010047402, 3007051929, 3013194153, 3005180920, 3007993775, 1000139987, 3002808269, 1000306303, 3003414678, 3009887475, 3003015552, 3010065126, 3004976965, 3006085220, 3012552981, 3008395353, 3009871135, 3002924544, 3008812560, 3006017180, 3000206435, 3033509898, 3006984710, 3003386935, 3010057495, 3006563559, 3007740680, 3000718467, 3017397663, 3011189525, 3010009693, 3010375065, 3010370880 +114 more