The following data is part of a premarket notification filed by The Jerome Group, Inc. with the FDA for Ceramic Tipped Skull Pin.
| Device ID | K040363 |
| 510k Number | K040363 |
| Device Name: | CERAMIC TIPPED SKULL PIN |
| Classification | Fixation Accessory |
| Applicant | THE JEROME GROUP, INC. 305 HARPER DR. Moorestown, NJ 08057 |
| Contact | Ronald Kowalski |
| Correspondent | Ronald Kowalski THE JEROME GROUP, INC. 305 HARPER DR. Moorestown, NJ 08057 |
| Product Code | LYT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-13 |
| Decision Date | 2004-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05690977368965 | K040363 | 000 |
| 05690977194090 | K040363 | 000 |
| 05690977192577 | K040363 | 000 |
| 05690977084544 | K040363 | 000 |
| 05690977084490 | K040363 | 000 |
| 05690977084254 | K040363 | 000 |