The following data is part of a premarket notification filed by Azurmeds Inc. with the FDA for Ltj Screws And Washer.
Device ID | K210268 |
510k Number | K210268 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-01 |
Decision Date | 2021-02-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00810041623638 | K210268 | 000 |
00810041623379 | K210268 | 000 |
00810041623362 | K210268 | 000 |
00810041623355 | K210268 | 000 |
00810041623348 | K210268 | 000 |
00810041623331 | K210268 | 000 |
00810041623324 | K210268 | 000 |
00810041623317 | K210268 | 000 |
00810041623300 | K210268 | 000 |
00810041623409 | K210268 | 000 |
00810041623430 | K210268 | 000 |
00810041623508 | K210268 | 000 |
00810041623607 | K210268 | 000 |
00810041623577 | K210268 | 000 |
00810041623560 | K210268 | 000 |
00810041623553 | K210268 | 000 |
00810041623546 | K210268 | 000 |
00810041623539 | K210268 | 000 |
00810041623522 | K210268 | 000 |
00810041623515 | K210268 | 000 |
00810041623034 | K210268 | 000 |