The following data is part of a premarket notification filed by Hogan Lovells Us Llp with the FDA for Calypso System.
| Device ID | K120564 |
| 510k Number | K120564 |
| Device Name: | CALYPSO SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | HOGAN LOVELLS US LLP 1835 MARKET ST 29TH FL Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan HOGAN LOVELLS US LLP 1835 MARKET ST 29TH FL Philadelphia, PA 19103 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| 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 | 2012-02-24 |
| Decision Date | 2012-07-16 |
| Summary: | summary |