ATLAS SPINE VERTEBRAL BODY REPLACEMENT— 510(k) K071497
Substantially EquivalentAtlas Spine, Inc.
FDA 510(k) clearance K071497 for ATLAS SPINE VERTEBRAL BODY REPLACEMENT, Substantially Equivalent on 2007-06-29. Applicant: Atlas Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Atlas Spine, Inc.
- Product code
- Code MQP
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Jupiter, FL, US
Recent devices under product code MQP
view allMore clearances from Atlas Spine, Inc.
view all- K252822 — Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
- K252560 — Atlas Spine HiRISE Expandable Cervical Corpectomy System
- K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System
- K243191 — Atlas Spine Lateral Expandable Interbody System
- K202302 — Atlas Spine Rebar (Ti) Spacer System
Adverse events under product code MQP
product code MQP- Injury
- 372
- Malfunction
- 519
- Total
- 891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.