CLEARED UNDER GRAFTON II EDBM
FDA 510(k) clearance K122513 · decided 2013-03-06
Clearance details
- K-number
- K122513
- Device name
- CLEARED UNDER GRAFTON II EDBM
- Applicant
- Medtronic Sofamor Danek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-08-17
- Decision date
- 2013-03-06
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- MBP
- Device class
- 2
- Regulation number
- 888.3045
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PRESTIGE CERVICAL DISC SYSTEM (P060018/S005) | Medtronic Sofamor Danek, Inc. | 2016-08-11 |
| PRESTIGE® Cervical Disc (P060018/S004) | Medtronic Sofamor Danek, Inc. | 2016-07-20 |
| X-STOP LTOS (P040001/S021) | Medtronic Sofamor Danek, Inc. | 2014-12-12 |
| X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM (P040001/S022) | Medtronic Sofamor Danek, Inc. | 2014-10-24 |
| PRESTIGE CERVICAL DISC (P060018/S003) | Medtronic Sofamor Danek, Inc. | 2013-07-12 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S020) | Medtronic Sofamor Danek, Inc. | 2012-07-25 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S019) | Medtronic Sofamor Danek, Inc. | 2011-05-04 |
| PRESTIGE CERVICAL DISC (P060018/S002) | Medtronic Sofamor Danek, Inc. | 2011-03-24 |