The following data is part of a premarket notification filed by Summit Spine with the FDA for Summit Spine Yellowstone Lumbar Interbody Fusion System.
Device ID | K170572 |
510k Number | K170572 |
Device Name: | Summit Spine Yellowstone Lumbar Interbody Fusion System |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | Summit Spine 2333 Airport Rd Georgetown, TX 78628 |
Contact | Eric Buescher |
Correspondent | Eric Buescher Summit Spine 2333 Airport Rd Georgetown, TX 78628 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-27 |
Decision Date | 2017-04-26 |
Summary: | summary |