FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Reliance Lumbar IBF System
K Number: K183049
·
Decision Feb 15, 2019
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
24
Review Days
105
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Basic Information
- Device Name
- Reliance Lumbar IBF System
- K Number
- K183049
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reliance Medical Systems, LLC
- Date Received
- November 2, 2018
- Decision Date
- February 15, 2019
- 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 |
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Other Clearances by Reliance Medical Systems, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K202266 | Reliance Cervical IBF System | Mar 29, 2022 | Substantially Equivalent |
| K210874 | Reliance Spinal Screw System | May 13, 2021 | Substantially Equivalent |
| K173283 | Reliance Lumbar IBF System | Jan 19, 2018 | Substantially Equivalent |
| K173102 | Reliance Cervical IBF System | Dec 29, 2017 | Substantially Equivalent |
| K172489 | Reliance Cervical IBF System | Sep 7, 2017 | Substantially Equivalent |
| K162066 | Reliance Spinal Screw System | Dec 2, 2016 | Substantially Equivalent |
| K160463 | Reliance Lumbar IBF System | May 20, 2016 | Substantially Equivalent |
| K152131 | Reliance Spinal Screw System | Sep 17, 2015 | Substantially Equivalent |
| K142269 | Reliance Cervical IBF System | Jun 9, 2015 | Substantially Equivalent |
| K142867 | Reliance Posterior Cervical-Thoracic System | Apr 29, 2015 | Substantially Equivalent |