The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Axsos Locked Plating System Line Extension Of 3mm Locking Inserts.
Device ID | K092419 |
510k Number | K092419 |
Device Name: | AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS |
Classification | Plate, Fixation, Bone |
Applicant | HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Melissa A Matarese |
Correspondent | Melissa A Matarese HOWMEDICA OSTEONICS CORP. 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-06 |
Decision Date | 2009-09-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613154089420 | K092419 | 000 |