The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Cohere Thoracolumbar Interbody System.
| Device ID | K193541 |
| 510k Number | K193541 |
| Device Name: | NuVasive Cohere Thoracolumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Michelle Cheung |
| Correspondent | Michelle Cheung NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517013255 | K193541 | 000 |
| 00887517020734 | K193541 | 000 |
| 00195377036025 | K193541 | 000 |
| 00195377036018 | K193541 | 000 |
| 00195377036001 | K193541 | 000 |
| 00195377035998 | K193541 | 000 |
| 00195377035981 | K193541 | 000 |
| 00195377035974 | K193541 | 000 |
| 00195377035967 | K193541 | 000 |
| 00195377035950 | K193541 | 000 |
| 00195377035943 | K193541 | 000 |
| 00195377035936 | K193541 | 000 |
| 00195377035929 | K193541 | 000 |
| 00195377035912 | K193541 | 000 |
| 00195377035905 | K193541 | 000 |
| 00195377034991 | K193541 | 000 |
| 00195377034984 | K193541 | 000 |
| 00195377034977 | K193541 | 000 |
| 00887517020741 | K193541 | 000 |
| 00887517020758 | K193541 | 000 |
| 00887517013248 | K193541 | 000 |
| 00887517013231 | K193541 | 000 |
| 00195377056993 | K193541 | 000 |
| 00195377056986 | K193541 | 000 |
| 00195377056979 | K193541 | 000 |
| 00195377056962 | K193541 | 000 |
| 00195377056955 | K193541 | 000 |
| 00887517020857 | K193541 | 000 |
| 00887517020840 | K193541 | 000 |
| 00887517020833 | K193541 | 000 |
| 00887517020826 | K193541 | 000 |
| 00887517020819 | K193541 | 000 |
| 00887517020802 | K193541 | 000 |
| 00887517020796 | K193541 | 000 |
| 00887517020789 | K193541 | 000 |
| 00887517020772 | K193541 | 000 |
| 00887517020765 | K193541 | 000 |
| 00195377034960 | K193541 | 000 |