The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Ortholoc(tm) 3di Locking Screws Ortholoc(tm) Bone Screws.
| Device ID | K120802 |
| 510k Number | K120802 |
| Device Name: | ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Sarah Holtgrewe |
| Correspondent | Sarah Holtgrewe WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-16 |
| Decision Date | 2012-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420114389 | K120802 | 000 |
| 00840420113979 | K120802 | 000 |
| 00840420113993 | K120802 | 000 |
| 00840420114013 | K120802 | 000 |
| 00840420114068 | K120802 | 000 |
| 00840420114075 | K120802 | 000 |
| 00840420114099 | K120802 | 000 |
| 00840420114242 | K120802 | 000 |
| 00840420114310 | K120802 | 000 |
| 00840420114365 | K120802 | 000 |
| 00840420113948 | K120802 | 000 |