The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hoffmann Ii Compact Baltimore Coupling.
Device ID | K031941 |
510k Number | K031941 |
Device Name: | HOFFMANN II COMPACT BALTIMORE COUPLING |
Classification | Component, Traction, Invasive |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Vivian Kelly |
Correspondent | Vivian Kelly HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Product Code | JEC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-24 |
Decision Date | 2003-07-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04546540701893 | K031941 | 000 |