The following data is part of a premarket notification filed by Choicespine Llc with the FDA for Harrier-sa Lumbar Interbody System.
| Device ID | K191367 |
| 510k Number | K191367 |
| Device Name: | Harrier-SA Lumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | ChoiceSpine LLC 400 Erin Drive Knoxville, TN 37922 |
| Contact | Kim Finch |
| Correspondent | Kim Finch ChoiceSpine LLC 400 Erin Drive Knoxville, TN 37922 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-22 |
| Decision Date | 2019-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996184137 | K191367 | 000 |
| 00840996184007 | K191367 | 000 |
| 00840996183994 | K191367 | 000 |
| 00840996183987 | K191367 | 000 |
| 00840996183970 | K191367 | 000 |
| 00840996183963 | K191367 | 000 |
| 00840996192965 | K191367 | 000 |
| 00840996192958 | K191367 | 000 |
| 00840996192569 | K191367 | 000 |
| 00840996192514 | K191367 | 000 |
| 00840996184014 | K191367 | 000 |
| 00840996184021 | K191367 | 000 |
| 00840996184038 | K191367 | 000 |
| 00840996184120 | K191367 | 000 |
| 00840996184113 | K191367 | 000 |
| 00840996184106 | K191367 | 000 |
| 00840996184090 | K191367 | 000 |
| 00840996184083 | K191367 | 000 |
| 00840996184076 | K191367 | 000 |
| 00840996184069 | K191367 | 000 |
| 00840996184052 | K191367 | 000 |
| 00840996184045 | K191367 | 000 |
| 00840996182119 | K191367 | 000 |