FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATLAS SPINE PIVOTING SYSTEM
K Number: K100743
·
Decision Aug 10, 2010
Classifications
1
FEI Numbers
418
Registration Numbers
418
Same Product Code
890
Applicant Total
15
Review Days
147
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Basic Information
- Device Name
- ATLAS SPINE PIVOTING SYSTEM
- K Number
- K100743
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atlas Spine, Inc.
- Date Received
- March 16, 2010
- Decision Date
- August 10, 2010
- 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 Atlas Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy System | Nov 10, 2025 | Substantially Equivalent |
| K251969 | Atlas Spine Project X Expandable Posterior Lumbar Interbody System | Aug 15, 2025 | Substantially Equivalent |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Nov 26, 2024 | Substantially Equivalent |
| K202302 | Atlas Spine Rebar (Ti) Spacer System | Oct 30, 2020 | Substantially Equivalent |
| K192570 | Atlas Spine Expandable Cervical Standalone Interbody System | Feb 28, 2020 | Substantially Equivalent |
| K182418 | V3 Segmental Plating System | Nov 29, 2018 | Substantially Equivalent |
| K180675 | Atlas Spine Expandable Cervical Interbody System | Jun 13, 2018 | Substantially Equivalent |
| K172334 | Ortus Expandable Lumbar Interbody Fusion System | Oct 25, 2017 | Substantially Equivalent |
| K162918 | Atlas Spine Expandable Interbody System | Feb 9, 2017 | Substantially Equivalent |
| K112759 | APCLO PEDICLE SCREW SYSTEMS | Oct 18, 2011 | Substantially Equivalent |