The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Sdb Cerclage System.
| Device ID | K992616 |
| 510k Number | K992616 |
| Device Name: | SDB CERCLAGE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Burns Severson |
| Correspondent | Burns Severson PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-04 |
| Decision Date | 1999-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67929880110S0 | K992616 | 000 |
| H679498822S0 | K992616 | 000 |
| H679498821S0 | K992616 | 000 |
| H67929880101S0 | K992616 | 000 |
| H67929880001S0 | K992616 | 000 |
| H67961110501S0 | K992616 | 000 |
| H67949880001S0 | K992616 | 000 |