The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Modification To Endoscopic Spinal Access System.
| Device ID | K994425 |
| 510k Number | K994425 |
| Device Name: | MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM |
| Classification | Arthroscope |
| Applicant | ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Contact | Susan Finneran |
| Correspondent | Susan Finneran ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-30 |
| Decision Date | 2000-02-16 |
| Summary: | summary |