The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Innesis Peek Tl Cage.
| Device ID | K140577 |
| 510k Number | K140577 |
| Device Name: | INNESIS PEEK TL CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-06 |
| Decision Date | 2014-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809228124404 | K140577 | 000 |
| 08809228124213 | K140577 | 000 |
| 08809228124206 | K140577 | 000 |
| 08809228124190 | K140577 | 000 |
| 08809228124183 | K140577 | 000 |
| 08809228124176 | K140577 | 000 |
| 08809228124169 | K140577 | 000 |
| 08809228124152 | K140577 | 000 |
| 08809228124145 | K140577 | 000 |
| 08809228124138 | K140577 | 000 |
| 08809228124121 | K140577 | 000 |
| 08809228124114 | K140577 | 000 |
| 08809228124107 | K140577 | 000 |
| 08809228124091 | K140577 | 000 |
| 08809228124084 | K140577 | 000 |
| 08809228124077 | K140577 | 000 |
| 08809228124060 | K140577 | 000 |
| 08809228124220 | K140577 | 000 |
| 08809228124237 | K140577 | 000 |
| 08809228124398 | K140577 | 000 |
| 08809228124381 | K140577 | 000 |
| 08809228124374 | K140577 | 000 |
| 08809228124367 | K140577 | 000 |
| 08809228124350 | K140577 | 000 |
| 08809228124343 | K140577 | 000 |
| 08809228124336 | K140577 | 000 |
| 08809228124329 | K140577 | 000 |
| 08809228124312 | K140577 | 000 |
| 08809228124305 | K140577 | 000 |
| 08809228124299 | K140577 | 000 |
| 08809228124282 | K140577 | 000 |
| 08809228124275 | K140577 | 000 |
| 08809228124268 | K140577 | 000 |
| 08809228124251 | K140577 | 000 |
| 08809228124244 | K140577 | 000 |
| 08809228124053 | K140577 | 000 |