The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Proliant Polyaxial Pedicle Screw System.
| Device ID | K102870 |
| 510k Number | K102870 |
| Device Name: | EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Vladislava Zaitseva |
| Correspondent | Vladislava Zaitseva EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2011-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996176392 | K102870 | 000 |