The following data is part of a premarket notification filed by Osseus Fusion Systems with the FDA for Pisces-sa Standalone Alif Interbody System.
Device ID | K213935 |
510k Number | K213935 |
Device Name: | PISCES-SA Standalone ALIF Interbody System |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | Osseus Fusion Systems 1931 Greenville Ave Suite 200 Dallas, TX 75206 |
Contact | Jonathan Rosen |
Correspondent | Daniel Johnson Jalex Medical LLC 27865 Clemens Rd Suite 3 Westlake, OH 44145 |
Product Code | OVD |
Subsequent Product Code | MAX |
Subsequent Product Code | PHM |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-12-16 |
Decision Date | 2022-05-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
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