The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Incorporated with the FDA for Cd Horizon Growth Rod Conversion Set.
| Device ID | K150200 |
| 510k Number | K150200 |
| Device Name: | CD HORIZON Growth Rod Conversion Set |
| Classification | Growing Rod System |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INCORPORATED 1800 PYRAMID PLACE Memphis, TN 38132 -3576 |
| Contact | Lee Grant |
| Correspondent | Lee Grant MEDTRONIC SOFAMOR DANEK USA, INCORPORATED 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | PGM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-29 |
| Decision Date | 2015-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169500709 | K150200 | 000 |
| 00643169500518 | K150200 | 000 |
| 00643169500501 | K150200 | 000 |
| 00643169500495 | K150200 | 000 |
| 00643169500488 | K150200 | 000 |
| 00643169500471 | K150200 | 000 |
| 00643169500464 | K150200 | 000 |
| 00643169500457 | K150200 | 000 |
| 00643169500433 | K150200 | 000 |
| 00643169500426 | K150200 | 000 |
| 00643169500419 | K150200 | 000 |
| 00643169500402 | K150200 | 000 |
| 00643169500396 | K150200 | 000 |
| 00643169500389 | K150200 | 000 |
| 00643169500372 | K150200 | 000 |
| 00643169500525 | K150200 | 000 |
| 00643169500532 | K150200 | 000 |
| 00643169500686 | K150200 | 000 |
| 00643169500679 | K150200 | 000 |
| 00643169500662 | K150200 | 000 |
| 00643169500655 | K150200 | 000 |
| 00643169500648 | K150200 | 000 |
| 00643169500631 | K150200 | 000 |
| 00643169500624 | K150200 | 000 |
| 00643169500600 | K150200 | 000 |
| 00643169500594 | K150200 | 000 |
| 00643169500587 | K150200 | 000 |
| 00643169500570 | K150200 | 000 |
| 00643169500563 | K150200 | 000 |
| 00643169500556 | K150200 | 000 |
| 00643169500549 | K150200 | 000 |
| 20643169545629 | K150200 | 000 |