SternaLock® 360 Sternal Closure System
Plate, Fixation, Bone
BIOMET MICROFIXATION
The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Sternalock® 360 Sternal Closure System.
Pre-market Notification Details
| Device ID | K151019 |
| 510k Number | K151019 |
| Device Name: | SternaLock® 360 Sternal Closure System |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET MICROFIXATION 1520 TRADEPORT DRIVE Jacksonville, FL 32218 |
| Contact | Lauren Jasper |
| Correspondent | Lauren Jasper BIOMET MICROFIXATION 1520 TRADEPORT DRIVE Jacksonville, FL 32218 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-16 |
| Decision Date | 2015-11-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841036192136 | K151019 | 000 |
| 00888233026598 | K151019 | 000 |
| 00888233026604 | K151019 | 000 |
| 00841036190019 | K151019 | 000 |
| 00841036190026 | K151019 | 000 |
| 00841036190200 | K151019 | 000 |
| 00841036190217 | K151019 | 000 |
| 00841036190224 | K151019 | 000 |
| 00841036190231 | K151019 | 000 |
| 00841036190668 | K151019 | 000 |
| 00841036192143 | K151019 | 000 |
| 00841036202484 | K151019 | 000 |
| 00841036275266 | K151019 | 000 |
| 00841036275273 | K151019 | 000 |
| 00888233026581 | K151019 | 000 |
Trademark Results [SternaLock]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STERNALOCK 78582263 3076302 Live/Registered |
ZIMMER BIOMET CMF AND THORACIC, LLC 2005-03-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.