FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Life Spine SIMPACT Sacroiliac Joint Fixation System
K Number: K201538
·
Decision Sep 18, 2020
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
130
Applicant Total
84
Review Days
101
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Basic Information
- Device Name
- Life Spine SIMPACT Sacroiliac Joint Fixation System
- K Number
- K201538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Spine, Inc.
- Date Received
- June 9, 2020
- Decision Date
- September 18, 2020
- Product Code
- OUR
- 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 |
|---|---|---|---|
| OUR | Sacroiliac Joint Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Life Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Jun 2, 2026 | Substantially Equivalent |
| K260837 | VersaLift Expandable System | May 12, 2026 | Substantially Equivalent |
| K254274 | ARx® SAI Implant System | Apr 16, 2026 | Substantially Equivalent |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Jan 23, 2026 | Substantially Equivalent |
| K251502 | TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System | Jul 7, 2025 | Substantially Equivalent |
| K250373 | ProLift Expandable Spacer System | Apr 9, 2025 | Substantially Equivalent |
| K243668 | ProLift Pivot Expandable Spacer System | Jan 23, 2025 | Substantially Equivalent |
| K243369 | Cervical Plating System | Dec 11, 2024 | Substantially Equivalent |
| K242826 | ProLift Wedge Expandable Spacer System | Oct 8, 2024 | Substantially Equivalent |
| K241464 | ARx® SAI Implant System | Jul 29, 2024 | Substantially Equivalent |