The following data is part of a premarket notification filed by Intelifuse, Inc. with the FDA for Intelifuse, Inc. Warm System With Stimulinks.
| Device ID | K051408 |
| 510k Number | K051408 |
| Device Name: | INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS |
| Classification | Staple, Fixation, Bone |
| Applicant | INTELIFUSE, INC. 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Contact | Sharon Rockwell |
| Correspondent | Sharon Rockwell INTELIFUSE, INC. 5582 CHALON ROAD Yorba Linda, CA 92886 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2005-06-29 |
| Summary: | summary |