The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Innesis Peek Cervical Cage.
| Device ID | K132483 |
| 510k Number | K132483 |
| Device Name: | INNESIS PEEK CERVICAL CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | BK MEDITECH CO., LTD. PO BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan BK MEDITECH CO., LTD. PO BOX 560 Stillwater, MN 55082 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-08 |
| Decision Date | 2014-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809228122523 | K132483 | 000 |
| 08809228122424 | K132483 | 000 |
| 08809228122431 | K132483 | 000 |
| 08809228122448 | K132483 | 000 |
| 08809228122455 | K132483 | 000 |
| 08809228122462 | K132483 | 000 |
| 08809228122479 | K132483 | 000 |
| 08809228122486 | K132483 | 000 |
| 08809228122493 | K132483 | 000 |
| 08809228122509 | K132483 | 000 |
| 08809228122516 | K132483 | 000 |
| 08809228122417 | K132483 | 000 |