The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Quadrant Retractor System.
| Device ID | K043602 |
| 510k Number | K043602 |
| Device Name: | QUADRANT RETRACTOR SYSTEM |
| Classification | Retractor |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | GAD |
| Subsequent Product Code | FSZ |
| Subsequent Product Code | NBH |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-29 |
| Decision Date | 2005-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074055251 | K043602 | 000 |
| 00885074055121 | K043602 | 000 |
| 00885074055138 | K043602 | 000 |
| 00885074055152 | K043602 | 000 |
| 00885074055169 | K043602 | 000 |
| 00885074055176 | K043602 | 000 |
| 00885074055190 | K043602 | 000 |
| 00885074055206 | K043602 | 000 |
| 00885074055213 | K043602 | 000 |
| 00885074055220 | K043602 | 000 |
| 00885074042497 | K043602 | 000 |