The following data is part of a premarket notification filed by Clariance with the FDA for Idys Lif Cages.
| Device ID | K131178 |
| 510k Number | K131178 |
| Device Name: | IDYS LIF CAGES |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CLARIANCE 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan, Esq. |
| Correspondent | Janice M Hogan, Esq. CLARIANCE 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-25 |
| Decision Date | 2013-10-10 |
| Summary: | summary |