The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Accp System Line Extension.
Device ID | K992344 |
510k Number | K992344 |
Device Name: | OSTEONICS ACCP SYSTEM LINE EXTENSION |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Kate Sutton |
Correspondent | Kate Sutton HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-14 |
Decision Date | 1999-07-30 |
Summary: | summary |