The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Laboratories Bone Screw.
| Device ID | K940690 |
| 510k Number | K940690 |
| Device Name: | PIONEER LABORATORIES BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Burns O Severson |
| Correspondent | Burns O Severson PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-16 |
| Decision Date | 1994-11-22 |