# Innovative Surgical Designs, Inc.

- Location (FDA's records): Bloomington, IN
- FDA decisions: 9 (2013–2022): 9 510(k) clearances
- Names in FDA's records: Innovative Surgical Designs, Inc. (7); Innovative Surgical Designs (2)
- Product codes: NKB (7), MNH (1), MNI (1)
- 510(k) review time since 2016: median 61 days, against 69 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medtronic Sofamor Danek USA, Inc.: 4 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Depuyacromed: 4 (https://510kreport.com/company/depuyacromed)
- Buckman Co., Inc.: 2 (https://510kreport.com/company/buckman)
- Cross Medical Products, Inc.: 2 (https://510kreport.com/company/cross-medical-products)

## Its most-cited devices
- K130958: True Spinal Fixation System (2013), cited by 1

## Recent decisions
- 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)

Source page: https://510kreport.com/company/innovative-surgical-designs