The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Suture Wires And Wire Loops.
| Device ID | K150889 |
| 510k Number | K150889 |
| Device Name: | Suture Wires And Wire Loops |
| Classification | Cerclage, Fixation |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Patrick Mccullagh |
| Correspondent | Dorothy Snyder ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-02 |
| Decision Date | 2015-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024038103 | K150889 | 000 |
| 00889024038097 | K150889 | 000 |
| 00889024038080 | K150889 | 000 |
| 00889024038073 | K150889 | 000 |
| 00889024038066 | K150889 | 000 |
| 00889024038059 | K150889 | 000 |
| 00889024038042 | K150889 | 000 |
| 00889024038035 | K150889 | 000 |
| 00889024035546 | K150889 | 000 |