# Integrity Implants, Inc.

- Location (FDA's records): Palm Beach Gardens, FL
- FDA decisions: 11 (2019–2023): 11 510(k) clearances
- Product codes: MAX (7), NKB (3), OLO (1)
- 510(k) review time since 2016: median 126 days, against 95 for FDA's reviews in the same codes and years (3 of 11 faster)
- Predicates its devices cite: 39 (15 its own); citations of its devices by later devices: 24 (15 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Globus Medical, Inc.: 5 (https://510kreport.com/company/globus-medical)
- Ouroboros Medical: 4 (https://510kreport.com/company/ouroboros-medical)
- Innovasive, Inc.: 2 (https://510kreport.com/company/innovasive)
- Nu Vasive, Incorporated: 2 (https://510kreport.com/company/nu-vasive)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Amendia, Inc.: 2 (https://510kreport.com/company/amendia)
- Spinefrontier, Inc.: 1 (https://510kreport.com/company/spinefrontier)
- Tyber Medical, LLC: 1 (https://510kreport.com/company/tyber-medical)

## Firms that cite its devices most
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Integrity Implants Inc. Dba Accelus: 2 (https://510kreport.com/company/integrity-implants-dba-accelus)
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Allumin8, Inc.: 1 (https://510kreport.com/company/allumin8)
- Shanghai Iatrical-Ti Technologies CO, Ltd.: 1 (https://510kreport.com/company/shanghai-iatrical-ti-technologies)
- Alphatec Spine, Inc.: 1 (https://510kreport.com/company/alphatec-spine)
- Zavation Medical Products, LLC: 1 (https://510kreport.com/company/zavation-medical-products)

## Its most-cited devices
- K190360: LineSider™ Spinal System (2019), cited by 5
- K183184: FlareHawk Interbody Fusion System (2019), cited by 5
- K182114: FlareHawk Interbody Fusion System (2019), cited by 3
- K203038: Toro-L Interbody Fusion System (2021), cited by 2
- K202198: FlareHawk Interbody Fusion System (2020), cited by 2
- K203367: LineSider™ Spinal System (2020), cited by 2

## Recent decisions
- K231098: LineSider® Spinal System (Aug 7, 2023)
- K213355: Toro-L Interbody Fusion System (Mar 25, 2022)
- K220453: FlareHawk Interbody Fusion System (Mar 24, 2022)
- K212088: Integrity Implants Navigated Instruments (Dec 23, 2021)
- K203038: Toro-L Interbody Fusion System (Mar 26, 2021)
- K203367: LineSider™ Spinal System (Dec 3, 2020)
- K202198: FlareHawk Interbody Fusion System (Nov 3, 2020)
- K201367: FlareHawk TiHawk9 Interbody Fusion System (Sep 23, 2020)

Source page: https://510kreport.com/company/integrity-implants