N22 Offset Humeral Head
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
- 2026-09-08
- Decision code
- SESE
- Country code
- US
- Device name
- N22 Offset Humeral Head
- Advisory committee
- OR
- Contact
- Mark Hanes
- K number
- K262173
- State
- MI
- Date received
- 2026-06-26
- 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
- 9616671, 2249615, 1221934, 3013176080, 3000264985, 1834331, 2029275, 3026771806, 3005751028, 3009475821, 3007539489, 3010057495, 3017397663, 3005061536, 1835831, 3010386387, 3012523063, 3015516266, 3004748528, 3006984710, 3009532798, 3008110533, 1038671, 3000931034, 3011189525, 3013086329, 1450662, 3006128100, 3011943495, 3015916578, 1833986, 3004153896, 2133928, 3016438694, 3002808022, 1825034, 3008395353, 3004641308, 3009887475, 3020745236 +115 more
- FEI number
- 1000118610, 1221934, 3013176080, 3000264985, 3003714383, 1000116116, 3026771806, 3005751028, 3009475821, 3007539489, 3010057495, 3017397663, 3005061536, 3010386387, 3012523063, 3015516266, 3004748528, 3006984710, 3002807113, 3009532798, 3008110533, 1038671, 3000931034, 3011189525, 3013086329, 1450662, 3006128100, 3011943495, 3015916578, 1000221916, 3004153896, 1000306303, 3001236277, 3016438694, 3002808022, 1825034, 3008395353, 3004641308, 3009887475, 3020745236 +115 more