The following data is part of a premarket notification filed by Amendia Inc. with the FDA for Apollo Suture Anchor System And Titan Screws.
| Device ID | K133036 |
| 510k Number | K133036 |
| Device Name: | APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | AMENDIA INC. 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen AMENDIA INC. 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-26 |
| Decision Date | 2014-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812171023722 | K133036 | 000 |
| 00842962103562 | K133036 | 000 |
| 00842962103555 | K133036 | 000 |
| 00842962103548 | K133036 | 000 |
| 00842962103531 | K133036 | 000 |
| 00842962103524 | K133036 | 000 |
| 00842962103470 | K133036 | 000 |
| 00842962103463 | K133036 | 000 |
| 00842962103456 | K133036 | 000 |
| 00842962103449 | K133036 | 000 |
| 00842962103432 | K133036 | 000 |
| 00842962103579 | K133036 | 000 |
| 00812171023357 | K133036 | 000 |
| 00812171023715 | K133036 | 000 |
| 00812171023708 | K133036 | 000 |
| 00812171023678 | K133036 | 000 |
| 00812171023661 | K133036 | 000 |
| 00812171023654 | K133036 | 000 |
| 00812171023425 | K133036 | 000 |
| 00812171023418 | K133036 | 000 |
| 00812171023401 | K133036 | 000 |
| 00812171023371 | K133036 | 000 |
| 00812171023364 | K133036 | 000 |
| 00842962103425 | K133036 | 000 |