The following data is part of a premarket notification filed by Jace Medical Llc with the FDA for Sternal Closure System.
| Device ID | K142484 |
| 510k Number | K142484 |
| Device Name: | Sternal Closure System |
| Classification | Plate, Fixation, Bone |
| Applicant | JACE Medical LLC 536 East 200 North Warsaw, IN 46582 |
| Contact | Justin May |
| Correspondent | Karen E Warden BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 -2141 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDQ |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-04 |
| Decision Date | 2014-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888233069786 | K142484 | 000 |
| 00888233069779 | K142484 | 000 |
| 00888233069762 | K142484 | 000 |
| 00888233069755 | K142484 | 000 |
| 00888233069458 | K142484 | 000 |
| 00888233069441 | K142484 | 000 |