The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Silicoat Sternal Cable.
| Device ID | K993286 |
| 510k Number | K993286 |
| Device Name: | PIONEER SILICOAT STERNAL CABLE |
| Classification | Cerclage, Fixation |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Amy H Mimmaerts |
| Correspondent | Amy H Mimmaerts PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-01 |
| Decision Date | 1999-11-23 |
| Summary: | summary |