The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Bremer Halo System Titanium Skull Pin.
| Device ID | K993099 |
| 510k Number | K993099 |
| Device Name: | BREMER HALO SYSTEM TITANIUM SKULL PIN |
| Classification | Component, Traction, Invasive |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Frank Mass |
| Correspondent | Frank Mass DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-16 |
| Decision Date | 1999-12-15 |
| Summary: | summary |