The following data is part of a premarket notification filed by Clariance with the FDA for Erisma-lp.
| Device ID | K120469 |
| 510k Number | K120469 |
| Device Name: | ERISMA-LP |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | CLARIANCE 3101 NEAL COURT Cumming, GA 30041 |
| Contact | William Jackson |
| Correspondent | William Jackson CLARIANCE 3101 NEAL COURT Cumming, GA 30041 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-16 |
| Decision Date | 2012-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700780639182 | K120469 | 000 |