The following data is part of a premarket notification filed by International Life Sciences with the FDA for Atl Anchors.
| Device ID | K200503 |
| 510k Number | K200503 |
| Device Name: | ATL Anchors |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | International Life Sciences 2252 Northwest Parkway SE Suite G Marietta, GA 30067 |
| Contact | Tiffini Wittwer |
| Correspondent | Tiffini Wittwer International Life Sciences 2252 Northwest Parkway SE Suite G Marietta, GA 30067 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003396156 | K200503 | 000 |
| 00850003396149 | K200503 | 000 |
| 00850003396262 | K200503 | 000 |
| 00850003396255 | K200503 | 000 |