The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Horizontal-vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems.
| Device ID | K161992 |
| 510k Number | K161992 |
| Device Name: | Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Jennifer Siegel |
| Correspondent | Jennifer Siegel INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-19 |
| Decision Date | 2016-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830055352 | K161992 | 000 |
| 00382830057240 | K161992 | 000 |
| 00382830057257 | K161992 | 000 |
| 00382830057264 | K161992 | 000 |
| 00382830057271 | K161992 | 000 |
| 00382830053600 | K161992 | 000 |
| 00382830055161 | K161992 | 000 |
| 00382830055185 | K161992 | 000 |
| 00382830055277 | K161992 | 000 |
| 00382830055345 | K161992 | 000 |
| 00382830057233 | K161992 | 000 |