The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc with the FDA for Pioneer Spinal Process Fusion Plate.
| Device ID | K110367 |
| 510k Number | K110367 |
| Device Name: | PIONEER SPINAL PROCESS FUSION PLATE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Emily M Downs |
| Correspondent | Emily M Downs PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-08 |
| Decision Date | 2011-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846468047740 | K110367 | 000 |
| 00846468047733 | K110367 | 000 |
| 00846468047726 | K110367 | 000 |
| 00846468047719 | K110367 | 000 |
| 00846468047702 | K110367 | 000 |