The following data is part of a premarket notification filed by Azurmeds Inc. with the FDA for Ltj Screws And Washer.
| Device ID | K200987 |
| 510k Number | K200987 |
| Device Name: | LTJ Screws And Washer |
| Classification | Screw, Fixation, Bone |
| Applicant | AzurMeds Inc. 4809 N Ravenswood Avenue Suite 119 Chicago, IL 60604 |
| Contact | Jean-marie Berger |
| Correspondent | Jean-marie Berger AzurMeds Inc. 4809 N Ravenswood Avenue Suite 119 Chicago, IL 60604 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-15 |
| Decision Date | 2020-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810041621634 | K200987 | 000 |
| 00810041621405 | K200987 | 000 |
| 00810041621375 | K200987 | 000 |
| 00810041621368 | K200987 | 000 |
| 00810041621351 | K200987 | 000 |
| 00810041621344 | K200987 | 000 |
| 00810041621337 | K200987 | 000 |
| 00810041621320 | K200987 | 000 |
| 00810041621313 | K200987 | 000 |
| 00810041621436 | K200987 | 000 |
| 00810041621504 | K200987 | 000 |
| 00810041621603 | K200987 | 000 |
| 00810041621573 | K200987 | 000 |
| 00810041621566 | K200987 | 000 |
| 00810041621559 | K200987 | 000 |
| 00810041621542 | K200987 | 000 |
| 00810041621535 | K200987 | 000 |
| 00810041621528 | K200987 | 000 |
| 00810041621511 | K200987 | 000 |
| 00810041621030 | K200987 | 000 |