The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Horizontal-vertical Lumbar Valve And Spetzler Lumbar Peritoneal Shunt Systems.
| Device ID | K101381 |
| 510k Number | K101381 |
| Device Name: | HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Donna Millisky |
| Correspondent | Donna Millisky INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-17 |
| Decision Date | 2011-07-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830055727 | K101381 | 000 |
| 10381780035404 | K101381 | 000 |
| 10381780035398 | K101381 | 000 |
| 10381780035381 | K101381 | 000 |
| 10381780035374 | K101381 | 000 |
| 10381780035367 | K101381 | 000 |
| 10381780035350 | K101381 | 000 |
| 10381780034469 | K101381 | 000 |
| 10381780034452 | K101381 | 000 |
| 10381780024408 | K101381 | 000 |
| 10381780024415 | K101381 | 000 |
| 00382830055956 | K101381 | 000 |
| 00382830056175 | K101381 | 000 |
| 00382830057424 | K101381 | 000 |
| 10381780072539 | K101381 | 000 |
| 10381780071631 | K101381 | 000 |
| 10381780071624 | K101381 | 000 |
| 10381780071617 | K101381 | 000 |
| 10381780024422 | K101381 | 000 |
| 10381780034445 | K101381 | 000 |