The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Pi Drive Plus Motor, Extender.
| Device ID | K152641 |
| 510k Number | K152641 |
| Device Name: | Pi Drive Plus Motor, Extender |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | STRYKER CORPORATION 400 E. MILHAM AVENUE Kalamazoo, MI 49001 |
| Contact | Deval Patel |
| Correspondent | Julia Helgeson STRYKER CORPORATION 4100 E. MILHAM AVENUE Kalamazoo, MI 49001 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-15 |
| Decision Date | 2015-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327177367 | K152641 | 000 |
| 07613327177350 | K152641 | 000 |