Integra Burlington MA, Inc.
FDA Regulatory Profile
Integra Burlington MA, Inc. appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1030-2013, Class II) was initiated on March 18, 2013. Its most recent 510(k) clearance was granted on February 22, 2012.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1030-2013 | Class II | Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative c | March 18, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113570 | INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP | February 22, 2012 |