The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Thoracolumbar Plate, Model 1208-41fxx, Lumber Plate, Model 1208-41fxxl, Sacral Plate, Model 1208-41fxxs.
| Device ID | K091253 |
| 510k Number | K091253 |
| Device Name: | THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Richard W Woods |
| Correspondent | Richard W Woods K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-29 |
| Decision Date | 2009-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857019249 | K091253 | 000 |
| 10888857019041 | K091253 | 000 |
| 10888857019058 | K091253 | 000 |
| 10888857019065 | K091253 | 000 |
| 10888857019072 | K091253 | 000 |
| 10888857019089 | K091253 | 000 |
| 10888857019096 | K091253 | 000 |
| 10888857019102 | K091253 | 000 |
| 10888857019119 | K091253 | 000 |
| 10888857019126 | K091253 | 000 |
| 10888857019133 | K091253 | 000 |
| 10888857019157 | K091253 | 000 |
| 10888857019164 | K091253 | 000 |
| 10888857019171 | K091253 | 000 |
| 10888857019188 | K091253 | 000 |
| 10888857019201 | K091253 | 000 |
| 10888857019218 | K091253 | 000 |
| 10888857019232 | K091253 | 000 |
| 10888857019034 | K091253 | 000 |