The following data is part of a premarket notification filed by Nlt Spine Ltd with the FDA for Espin System.
| Device ID | K133061 |
| 510k Number | K133061 |
| Device Name: | ESPIN SYSTEM |
| Classification | Arthroscope |
| Applicant | NLT SPINE LTD 555 13TH ST NW Washington, DC 20004 |
| Contact | John J Smith |
| Correspondent | John J Smith NLT SPINE LTD 555 13TH ST NW Washington, DC 20004 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2013-11-27 |
| Summary: | summary |