The following data is part of a premarket notification filed by Choice Spine, Lp with the FDA for Oria Natura Spacer.
Device ID | K073669 |
510k Number | K073669 |
Device Name: | ORIA NATURA SPACER |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | CHOICE SPINE, LP 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
Contact | Karen E Warden |
Correspondent | Karen E Warden CHOICE SPINE, LP 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-26 |
Decision Date | 2008-02-13 |
Summary: | summary |