Medical Device Manufacturer · US , Jupiter , FL

Integrity Implants, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2019

Recent clearances: LineSider® Spinal System, Toro-L Interbody Fusion System, FlareHawk Interbody Fusion System

11
Total
11
Cleared
0
Denied

FDA 510(k) Regulatory Record - Integrity Implants, Inc. Orthopedic ✕

11 devices
1-11 of 11
Cleared Aug 07, 2023
LineSider® Spinal System
K231098 · NKB
Orthopedic · 111d
Cleared Mar 25, 2022
Toro-L Interbody Fusion System
K213355 · MAX
Orthopedic · 164d
Cleared Mar 24, 2022
FlareHawk Interbody Fusion System
K220453 · MAX
Orthopedic · 35d
Cleared Dec 23, 2021
Integrity Implants Navigated Instruments
K212088 · OLO
Orthopedic · 170d
Cleared Mar 26, 2021
Toro-L Interbody Fusion System
K203038 · MAX
Orthopedic · 171d
Cleared Dec 03, 2020
LineSider™ Spinal System
K203367 · NKB
Orthopedic · 17d
Cleared Nov 03, 2020
FlareHawk Interbody Fusion System
K202198 · MAX
Orthopedic · 90d
Cleared Sep 23, 2020
FlareHawk TiHawk9 Interbody Fusion System
K201367 · MAX
Orthopedic · 124d
Cleared Jun 21, 2019
LineSider™ Spinal System
K190360 · NKB
Orthopedic · 126d
Cleared Apr 03, 2019
FlareHawk Interbody Fusion System
K183184 · MAX
Orthopedic · 135d
Cleared Jan 07, 2019
FlareHawk Interbody Fusion System
K182114 · MAX
Orthopedic · 154d
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