The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Hoffmann Ii External Fixation System 90 Degree Post.
| Device ID | K003848 |
| 510k Number | K003848 |
| Device Name: | HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST |
| Classification | Component, Traction, Invasive |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma 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 | 2000-12-12 |
| Decision Date | 2001-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327092653 | K003848 | 000 |