The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Acculif Tl And Pl Cage.
Device ID | K141217 |
510k Number | K141217 |
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 | Kristen Meany |
Correspondent | Kristen Meany STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-12 |
Decision Date | 2014-07-16 |
Summary: | summary |