The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Crw Stereotactic System.
| Device ID | K160811 |
| 510k Number | K160811 |
| Device Name: | CRW STEREOTACTIC SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Timothy Connors |
| Correspondent | Timothy Connors INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-24 |
| Decision Date | 2016-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M248LL011 | K160811 | 000 |
| M248UCHRA1 | K160811 | 000 |
| M248TAP1 | K160811 | 000 |
| M248HRW1 | K160811 | 000 |
| M248DHRSS51 | K160811 | 000 |
| M248DHRSL51 | K160811 | 000 |
| 10381780542308 | K160811 | 000 |
| 10381780252498 | K160811 | 000 |
| 00381780542288 | K160811 | 000 |
| M248UCHR1 | K160811 | 000 |
| M248UCHRAP1 | K160811 | 000 |
| M248UCHRCASE1 | K160811 | 000 |
| M248UCHRPP1 | K160811 | 000 |
| M248UCHRPA1 | K160811 | 000 |
| M433UCHRP1 | K160811 | 000 |
| M248UCHRHK1 | K160811 | 000 |
| M433UCHREBA1 | K160811 | 000 |
| M248UCHREB1 | K160811 | 000 |
| M433UCHRCBS1 | K160811 | 000 |
| M433UCHRCB11 | K160811 | 000 |
| 00381780542271 | K160811 | 000 |