FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ProLift Expandable System
K Number: K190488
·
Decision Jul 23, 2019
Classifications
1
FEI Numbers
422
Registration Numbers
422
Same Product Code
869
Applicant Total
29
Review Days
145
Basic Information
- Device Name
- ProLift Expandable System
- K Number
- K190488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Spine Inc.
- Date Received
- February 28, 2019
- Decision Date
- July 23, 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 Life Spine Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221806 | TruLift Lateral Expandable Spacer System & Lateral Plate System | Dec 5, 2022 | Substantially Equivalent |
| K202836 | GX Navigation Instrument System | Aug 19, 2021 | Substantially Equivalent |
| K201538 | Life Spine SIMPACT Sacroiliac Joint Fixation System | Sep 18, 2020 | Substantially Equivalent |
| K201721 | TruLift Expandable Spacer System | Sep 4, 2020 | Substantially Equivalent |
| K201500 | Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer | Aug 4, 2020 | Substantially Equivalent |
| K200896 | Solstice CCI | Apr 28, 2020 | Substantially Equivalent |
| K200070 | ARx Spinal System | Apr 23, 2020 | Substantially Equivalent |
| K200338 | ProLift Lateral Fixated | Apr 17, 2020 | Substantially Equivalent |
| K193258 | ProLift Expandable System | Jan 31, 2020 | Substantially Equivalent |
| K191834 | Stand-Alone ALIF Titanium System | Dec 16, 2019 | Substantially Equivalent |