The following data is part of a premarket notification filed by Corentec Co., Ltd with the FDA for Aegis & Aegis Ii Spinal System.
| Device ID | K092076 |
| 510k Number | K092076 |
| Device Name: | AEGIS & AEGIS II SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | CORENTEC CO., LTD 1129 BLOOMFIELD AVE West Caldwell, NJ 07006 |
| Contact | Robert Schiff |
| Correspondent | Robert Schiff CORENTEC CO., LTD 1129 BLOOMFIELD AVE West Caldwell, NJ 07006 |
| Product Code | MNI |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-09 |
| Decision Date | 2010-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806373812910 | K092076 | 000 |
| 08800017288116 | K092076 | 000 |
| 08800017288123 | K092076 | 000 |
| 08800017288130 | K092076 | 000 |
| 08800017288147 | K092076 | 000 |
| 08800017288154 | K092076 | 000 |
| 08800017288161 | K092076 | 000 |
| 08800017288178 | K092076 | 000 |
| 08800017288185 | K092076 | 000 |
| 08800017288109 | K092076 | 000 |