The following data is part of a premarket notification filed by Stryker Spine with the FDA for Anchor-l Lumbar Cage.
Device ID | K120869 |
510k Number | K120869 |
Device Name: | ANCHOR-L LUMBAR CAGE |
Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
Contact | Tiffani Rogers |
Correspondent | Tiffani Rogers STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
Product Code | OVD |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-03-22 |
Decision Date | 2012-10-25 |
Summary: | summary |