The following data is part of a premarket notification filed by Zimmer Knee Creations with the FDA for Accufill Bone Substitute Material.
| Device ID | K190814 |
| 510k Number | K190814 |
| Device Name: | AccuFill Bone Substitute Material |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Zimmer Knee Creations 841 Springdale Drive Exton, PA 19341 |
| Contact | David L. Nichols |
| Correspondent | Hollace Saas Rhodes Mcra, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-29 |
| Decision Date | 2019-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024205123 | K190814 | 000 |
| 00889024205192 | K190814 | 000 |
| 00889024205208 | K190814 | 000 |
| 00889024205215 | K190814 | 000 |
| 00889024205222 | K190814 | 000 |
| 00889024205239 | K190814 | 000 |
| 00889024205444 | K190814 | 000 |
| 00889024406476 | K190814 | 000 |
| 00889024406537 | K190814 | 000 |
| 00889024406544 | K190814 | 000 |
| 00889024205116 | K190814 | 000 |