The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Acculif Tl And Pl Cage.
Device ID | K152651 |
510k Number | K152651 |
Device Name: | AccuLIF TL And PL Cage |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
Contact | Aakash Jain |
Correspondent | Aakash Jain STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-09-16 |
Decision Date | 2015-12-15 |
Summary: | summary |