The following data is part of a premarket notification filed by Genesis Fracture Care, Inc. with the FDA for G3 Active Plate Large Fragment System.
| Device ID | K142938 |
| 510k Number | K142938 |
| Device Name: | G3 Active Plate Large Fragment System |
| Classification | Plate, Fixation, Bone |
| Applicant | GENESIS FRACTURE CARE, INC. 13568 SE 97th Ave. Suite 202 Clackamas, OR 97105 |
| Contact | Michael Bottlang |
| Correspondent | Christine Scifert MEMPHIS REGULATORY CONSULTING, LLC 3416 ROXEE RUN COVE Bartlette, TN 38133 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-09 |
| Decision Date | 2014-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866204000266 | K142938 | 000 |
| 00866204000259 | K142938 | 000 |
| 00866204000242 | K142938 | 000 |
| 00866204000235 | K142938 | 000 |
| 00866204000228 | K142938 | 000 |
| 00866204000211 | K142938 | 000 |
| 00866204000204 | K142938 | 000 |