ACCELL EVO3C
FDA 510(k) clearance K091193 · decided 2009-08-10
Clearance details
- K-number
- K091193
- Device name
- ACCELL EVO3C
- Applicant
- Isotis Orthobiologics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-23
- Decision date
- 2009-08-10
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- MBP
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 1321 recall (Z-1868-2014) | Integra LifeSciences Corp. | 2014-06-25 |