The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc with the FDA for Nb3d Bone Void Filler.
| Device ID | K132050 |
| 510k Number | K132050 |
| Device Name: | NB3D BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette, MI 49855 |
| Contact | Emily Downs |
| Correspondent | Emily Downs PIONEER SURGICAL TECHNOLOGY, INC 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 | 2013-07-02 |
| Decision Date | 2014-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846468087135 | K132050 | 000 |
| 00849777012478 | K132050 | 000 |
| 00849777012485 | K132050 | 000 |
| 00849777012492 | K132050 | 000 |
| 00849777012508 | K132050 | 000 |
| 00849777012515 | K132050 | 000 |
| 00849777012522 | K132050 | 000 |
| 00849777012539 | K132050 | 000 |
| 00846468049546 | K132050 | 000 |
| 00846468049553 | K132050 | 000 |
| 00846468049560 | K132050 | 000 |
| 00846468049577 | K132050 | 000 |
| 00846468087104 | K132050 | 000 |
| 00846468087111 | K132050 | 000 |
| 00846468087128 | K132050 | 000 |
| 00849777012461 | K132050 | 000 |