The following data is part of a premarket notification filed by Bm Korea Co., Ltd. with the FDA for Guardian Inflatable Bone Expander System.
| Device ID | K111593 |
| 510k Number | K111593 |
| Device Name: | GUARDIAN INFLATABLE BONE EXPANDER SYSTEM |
| Classification | Cement, Bone, Vertebroplasty |
| Applicant | BM KOREA CO., LTD. 1733 CANTON LANE Marietta, GA 30062 -2670 |
| Contact | Ronald D Arkin |
| Correspondent | Ronald D Arkin BM KOREA CO., LTD. 1733 CANTON LANE Marietta, GA 30062 -2670 |
| Product Code | NDN |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-07 |
| Decision Date | 2011-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809255544817 | K111593 | 000 |
| 08809255542707 | K111593 | 000 |
| 08809255544213 | K111593 | 000 |
| 08809255544169 | K111593 | 000 |