The following data is part of a premarket notification filed by Valeris Medical with the FDA for Apollo Suture Anchor System And Titan Screws.
| Device ID | K142230 |
| 510k Number | K142230 |
| Device Name: | Apollo Suture Anchor System And Titan Screws |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Valeris Medical 200 Cobb Pkw N,Bldg 200 Ste 210 Marietta, GA 30062 |
| Contact | Daniel Lanois |
| Correspondent | Cheryl L Wagoner Wagoner Consulting LLC P O Box 15729 Wilmington, NC 28408 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-13 |
| Decision Date | 2014-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818614021246 | K142230 | 000 |
| 10818614020560 | K142230 | 000 |
| 10818614020553 | K142230 | 000 |
| 00818614020488 | K142230 | 000 |
| 00818614020471 | K142230 | 000 |
| B048XTS65150 | K142230 | 000 |
| B048XTS55151 | K142230 | 000 |
| B048TS80120 | K142230 | 000 |
| B048TS70120 | K142230 | 000 |