The following data is part of a premarket notification filed by Choicespine, Lp with the FDA for Choicespine Stealth Cervical Spacer System.
| Device ID | K183397 |
| 510k Number | K183397 |
| Device Name: | ChoiceSpine Stealth Cervical Spacer System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | ChoiceSpine, LP 400 Erin Drive Knoxville, TN 37922 |
| Contact | Kim Finch |
| Correspondent | Kim Finch ChoiceSpine, LP 400 Erin Drive Knoxville, TN 37922 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-07 |
| Decision Date | 2019-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996192941 | K183397 | 000 |
| 00840996181815 | K183397 | 000 |
| 00840996181273 | K183397 | 000 |