FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Integrity Implants Navigated Instruments
K Number: K212088
·
Decision Dec 23, 2021
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
11
Review Days
170
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Basic Information
- Device Name
- Integrity Implants Navigated Instruments
- K Number
- K212088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integrity Implants, Inc.
- Date Received
- July 6, 2021
- Decision Date
- December 23, 2021
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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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 |
| 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 |
| K201367 | FlareHawk TiHawk9 Interbody Fusion System | Sep 23, 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 |