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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700780622511 | K131178 | 000 |
| 03700780600342 | K131178 | 000 |
| 03700780600335 | K131178 | 000 |
| 03700780600311 | K131178 | 000 |
| 03700780600298 | K131178 | 000 |
| 03700780600281 | K131178 | 000 |
| 03700780600274 | K131178 | 000 |
| 03700780600267 | K131178 | 000 |
| 03700780600243 | K131178 | 000 |
| 03700780600229 | K131178 | 000 |
| 03700780600212 | K131178 | 000 |
| 03700780600199 | K131178 | 000 |
| 03700780600182 | K131178 | 000 |
| 03700780600175 | K131178 | 000 |
| 03700780600168 | K131178 | 000 |
| 03700780600137 | K131178 | 000 |
| 03700780600359 | K131178 | 000 |
| 03700780600366 | K131178 | 000 |
| 03700780622481 | K131178 | 000 |
| 03700780604074 | K131178 | 000 |
| 03700780604067 | K131178 | 000 |
| 03700780604050 | K131178 | 000 |
| 03700780604043 | K131178 | 000 |
| 03700780604036 | K131178 | 000 |
| 03700780603787 | K131178 | 000 |
| 03700780603749 | K131178 | 000 |
| 03700780600465 | K131178 | 000 |
| 03700780600458 | K131178 | 000 |
| 03700780600441 | K131178 | 000 |
| 03700780600434 | K131178 | 000 |
| 03700780600427 | K131178 | 000 |
| 03700780600397 | K131178 | 000 |
| 03700780600373 | K131178 | 000 |
| 03700780600120 | K131178 | 000 |