The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (rti Surgical, I with the FDA for Nanoss Bioactive, Nanoss Bioactive Loaded, And Nanoss Bioactive Loaded Kit.
| Device ID | K141600 |
| 510k Number | K141600 |
| Device Name: | NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KIT |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Sarah Mcintyre |
| Correspondent | Sarah Mcintyre PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-06-16 |
| Decision Date | 2014-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849777012454 | K141600 | 000 |
| 00849777012447 | K141600 | 000 |
| 00849777012430 | K141600 | 000 |
| 00849777012423 | K141600 | 000 |
| 00849777012416 | K141600 | 000 |
| 00849777012409 | K141600 | 000 |
| 00849777012393 | K141600 | 000 |