The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Segmental System Xt Components.
| Device ID | K150028 |
| 510k Number | K150028 |
| Device Name: | Zimmer Segmental System XT Components |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Keith J. Proctor |
| Correspondent | Yoriko Kobayashi ZIMMER, INC./ ZIMMER, K.K. PO BOX 708 Warsaw, IN 46581 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-07 |
| Decision Date | 2015-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024196322 | K150028 | 000 |
| 00889024633896 | K150028 | 000 |
| 00889024633926 | K150028 | 000 |
| 00889024633933 | K150028 | 000 |
| 00889024195639 | K150028 | 000 |
| 00889024195677 | K150028 | 000 |
| 00889024195929 | K150028 | 000 |
| 00889024195936 | K150028 | 000 |
| 00889024195943 | K150028 | 000 |
| 00889024195950 | K150028 | 000 |
| 00889024196315 | K150028 | 000 |
| 00889024633889 | K150028 | 000 |