The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Charlotte (tm) Mtp Bone Fusion Plate System Hex Screw.
| Device ID | K141417 |
| 510k Number | K141417 |
| Device Name: | CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Contact | Leslie Fitch |
| Correspondent | Leslie Fitch WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-29 |
| Decision Date | 2014-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420108494 | K141417 | 000 |
| 00840420108302 | K141417 | 000 |
| 00840420108319 | K141417 | 000 |
| 00840420108326 | K141417 | 000 |
| 00840420108333 | K141417 | 000 |
| 00840420108340 | K141417 | 000 |
| 00840420108357 | K141417 | 000 |
| 00840420108364 | K141417 | 000 |
| 00840420108371 | K141417 | 000 |
| 00840420108418 | K141417 | 000 |
| 00840420108425 | K141417 | 000 |
| 00840420108432 | K141417 | 000 |
| 00840420108449 | K141417 | 000 |
| 00840420108456 | K141417 | 000 |
| 00840420108463 | K141417 | 000 |
| 00840420108470 | K141417 | 000 |
| 00840420108487 | K141417 | 000 |
| 00840420108296 | K141417 | 000 |