The following data is part of a premarket notification filed by Johnson & Johnson with the FDA for Spotlight Access System.
| Device ID | K112913 |
| 510k Number | K112913 |
| Device Name: | SPOTLIGHT ACCESS SYSTEM |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | JOHNSON & JOHNSON 325 Paramount Drive Raynham, MA 02767 |
| Contact | Laura Bleyendaal |
| Correspondent | Laura Bleyendaal JOHNSON & JOHNSON 325 Paramount Drive Raynham, MA 02767 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2011-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034358376 | K112913 | 000 |
| 10705034358314 | K112913 | 000 |