The following data is part of a premarket notification filed by Spine Smith Partners L.p. with the FDA for In:c2 Spinal Fixation System.
Device ID | K122630 |
510k Number | K122630 |
Device Name: | IN:C2 SPINAL FIXATION SYSTEM |
Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Applicant | SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin, TX 78701 |
Contact | Clifton (chris) Naivar |
Correspondent | Clifton (chris) Naivar SPINE SMITH PARTNERS L.P. 93 RED RIVER Austin, TX 78701 |
Product Code | OVE |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-28 |
Decision Date | 2012-12-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817771029822 | K122630 | 000 |
00817771029815 | K122630 | 000 |
00817771027637 | K122630 | 000 |