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 |