The following data is part of a premarket notification filed by K&j Consulting Corporation with the FDA for K&j Iva (acif, Dlif, Plif, Tlif, Alif) Peek Cage.
| Device ID | K212038 |
| 510k Number | K212038 |
| Device Name: | K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | K&J Consulting Corporation 2260 Glenview Dr Lansdale, PA 19446 |
| Contact | Barry E. Sands |
| Correspondent | Barry E. Sands RQMIS Inc. 110 Haverhill Road Suite 524 Amesbury, MA 01913 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-30 |
| Decision Date | 2021-08-27 |