The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Hoffmann Ii Compact External Fixation System.
Device ID | K971755 |
510k Number | K971755 |
Device Name: | HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM |
Classification | Component, Traction, Invasive |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | John Dichiara |
Correspondent | John Dichiara HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | JEC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-12 |
Decision Date | 1997-07-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613327092677 | K971755 | 000 |
07613327092646 | K971755 | 000 |
07613327092103 | K971755 | 000 |
07613327092080 | K971755 | 000 |
07613327091519 | K971755 | 000 |
07613327079135 | K971755 | 000 |
07613327072815 | K971755 | 000 |