The following data is part of a premarket notification filed by Smith & Nephew with the FDA for Novos-nail Limb Lengthening System (lls).
| Device ID | K163653 |
| 510k Number | K163653 |
| Device Name: | NOVOS-NAIL Limb Lengthening System (LLS) |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Smith & Nephew 1450 E Brooks Rd. Memphis, TN 38116 |
| Contact | Allison Chan |
| Correspondent | Allison Chan Smith & Nephew 1450 E Brooks Rd. Memphis, TN 38116 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-23 |
| Decision Date | 2017-10-13 |
| Summary: | summary |