The following data is part of a premarket notification filed by Neoss Limited with the FDA for Membrane Screws And Membrane Tacks.
| Device ID | K201561 |
| 510k Number | K201561 |
| Device Name: | Membrane Screws And Membrane Tacks |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | Neoss Limited Windsor House, Cornwall Rd Harrogate, GB Hg1 2pw |
| Contact | Stellan Sundstrom |
| Correspondent | Cherita James M Squared Associates, Inc 127 West 30th St Floor 9 New York, NY 10001 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-10 |
| Decision Date | 2020-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060440334290 | K201561 | 000 |
| 05060440334283 | K201561 | 000 |