The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Innesis Peek Cage.
| Device ID | K120464 |
| 510k Number | K120464 |
| Device Name: | INNESIS PEEK CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | BK MEDITECH CO., LTD. 8 EAST BROADWAY, STE 611 Salt Lake City, UT 84111 |
| Contact | Shin Kuk Yoo |
| Correspondent | Shin Kuk Yoo BK MEDITECH CO., LTD. 8 EAST BROADWAY, STE 611 Salt Lake City, UT 84111 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-15 |
| Decision Date | 2013-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809228120888 | K120464 | 000 |
| 08809228120727 | K120464 | 000 |
| 08809228120734 | K120464 | 000 |
| 08809228120741 | K120464 | 000 |
| 08809228120758 | K120464 | 000 |
| 08809228120765 | K120464 | 000 |
| 08809228120772 | K120464 | 000 |
| 08809228120789 | K120464 | 000 |
| 08809228120796 | K120464 | 000 |
| 08809228120802 | K120464 | 000 |
| 08809228120819 | K120464 | 000 |
| 08809228120826 | K120464 | 000 |
| 08809228120833 | K120464 | 000 |
| 08809228120840 | K120464 | 000 |
| 08809228120857 | K120464 | 000 |
| 08809228120864 | K120464 | 000 |
| 08809228120871 | K120464 | 000 |
| 08809228120710 | K120464 | 000 |