FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FlareHawk TiHawk9 Interbody Fusion System
K Number: K201367
·
Decision Sep 23, 2020
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
11
Review Days
124
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Basic Information
- Device Name
- FlareHawk TiHawk9 Interbody Fusion System
- K Number
- K201367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integrity Implants, Inc.
- Date Received
- May 22, 2020
- Decision Date
- September 23, 2020
- Product Code
- MAX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
FDA 510(k)
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Other Clearances by Integrity Implants, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231098 | LineSider® Spinal System | Aug 7, 2023 | Substantially Equivalent |
| K213355 | Toro-L Interbody Fusion System | Mar 25, 2022 | Substantially Equivalent |
| K220453 | FlareHawk Interbody Fusion System | Mar 24, 2022 | Substantially Equivalent |
| K212088 | Integrity Implants Navigated Instruments | Dec 23, 2021 | Substantially Equivalent |
| K203038 | Toro-L Interbody Fusion System | Mar 26, 2021 | Substantially Equivalent |
| K203367 | LineSider Spinal System | Dec 3, 2020 | Substantially Equivalent |
| K202198 | FlareHawk Interbody Fusion System | Nov 3, 2020 | Substantially Equivalent |
| K190360 | LineSider Spinal System | Jun 21, 2019 | Substantially Equivalent |
| K183184 | FlareHawk Interbody Fusion System | Apr 3, 2019 | Substantially Equivalent |
| K182114 | FlareHawk Interbody Fusion System | Jan 7, 2019 | Substantially Equivalent |