The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for S2 Tibial Nail.
Device ID | K022481 |
510k Number | K022481 |
Device Name: | S2 TIBIAL NAIL |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Karen Ariemma |
Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-29 |
Decision Date | 2002-08-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04546540397133 | K022481 | 000 |
04546540396358 | K022481 | 000 |
04546540396389 | K022481 | 000 |
04546540396396 | K022481 | 000 |
04546540396426 | K022481 | 000 |
04546540396433 | K022481 | 000 |
04546540397041 | K022481 | 000 |
04546540397058 | K022481 | 000 |
04546540397089 | K022481 | 000 |
04546540397096 | K022481 | 000 |
04546540397126 | K022481 | 000 |
04546540396341 | K022481 | 000 |