Innovative Surgical Designs, Inc.
Innovative Surgical Designs, Inc. has 0 FDA recalls, 3 inspections, 9 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Apr 26, 2018 · NAI
- Latest 510(k)
- Sep 16, 2022
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 9 | Oct 4, 2026 | Not stated | Current |
| Inspections | 3 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 26, 2018 | Bloomington, IN | Devices | No Action Indicated (NAI) | 3010586931 |
| Jul 27, 2017 | Bloomington, IN | Devices | Voluntary Action Indicated (VAI) | 3010586931 |
| Aug 27, 2015 | Bloomington, IN | Devices | Official Action Indicated (OAI) | 3010586931 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K220297 | True Tulip, True M.I.S. | Sep 16, 2022 |
| K212627 | True Tulip, True M.I.S. | Feb 18, 2022 |
| K210816 | True Tulip, True M.I.S. | May 18, 2021 |
| K201780 | True Tulip System, True M.I.S. System | Jul 22, 2020 |
| K181584 | Redi-Spine | Aug 10, 2018 |
| K171559 | True Spinal Fixation System | Jul 24, 2017 |
| K170710 | True Spinal Fixation System | Jul 14, 2017 |
| K133690 | TRUE SPINAL FUSSION SYSTEM | May 7, 2014 |
| K130958 | TRUE SPINAL FIXATION SYSTEM | Oct 17, 2013 |