ENDIUS ATAVI SYSTEM
FDA 510(k) clearance K053267 · decided 2006-01-13
Clearance details
- K-number
- K053267
- Device name
- ENDIUS ATAVI SYSTEM
- Applicant
- Endius, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-23
- Decision date
- 2006-01-13
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Plainville, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or RE recall (Z-1045-2013) | Zimmer, Inc. | 2013-04-01 |