The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Intervertebral Fusion Device System.
| Device ID | K073177 |
| 510k Number | K073177 |
| Device Name: | PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Contact | Jonathan M Gilbert |
| Correspondent | Jonathan M Gilbert PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2008-05-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00191083033686 | K073177 | 000 |