The following data is part of a premarket notification filed by Kyungwon Medical Co., Ltd. with the FDA for Polybone.
| Device ID | K070012 |
| 510k Number | K070012 |
| Device Name: | POLYBONE |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | KYUNGWON MEDICAL CO., LTD. 13340E FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Joo Yeon Lee |
| Correspondent | Joo Yeon Lee KYUNGWON MEDICAL CO., LTD. 13340E FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-12-27 |
| Summary: | summary |