The following data is part of a premarket notification filed by Orthosensor, Inc. with the FDA for Orthosensor Knee Balancer.
| Device ID | K130380 |
| 510k Number | K130380 |
| Device Name: | ORTHOSENSOR KNEE BALANCER |
| Classification | Intraoperative Orthopedic Joint Assessment Aid |
| Applicant | ORTHOSENSOR, INC. 1560 SAWGRASS CORPORATE PKWY. 4TH FLOOR Sunrise, FL 33323 |
| Contact | Kimberlee Washburn |
| Correspondent | Kimberlee Washburn ORTHOSENSOR, INC. 1560 SAWGRASS CORPORATE PKWY. 4TH FLOOR Sunrise, FL 33323 |
| Product Code | ONN |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816818021409 | K130380 | 000 |
| 00816818020914 | K130380 | 000 |
| 00816818020907 | K130380 | 000 |
| 00816818020891 | K130380 | 000 |
| 00816818020884 | K130380 | 000 |
| 00816818020877 | K130380 | 000 |
| 00816818020365 | K130380 | 000 |
| 00816818020358 | K130380 | 000 |
| 00816818020341 | K130380 | 000 |
| 00816818020334 | K130380 | 000 |
| 00816818020327 | K130380 | 000 |
| 00816818020921 | K130380 | 000 |
| 00816818021164 | K130380 | 000 |
| 00816818021294 | K130380 | 000 |
| 00816818021393 | K130380 | 000 |
| 00816818021386 | K130380 | 000 |
| 00816818021379 | K130380 | 000 |
| 00816818021362 | K130380 | 000 |
| 00816818021355 | K130380 | 000 |
| 00816818021348 | K130380 | 000 |
| 00816818021331 | K130380 | 000 |
| 00816818021324 | K130380 | 000 |
| 00816818021317 | K130380 | 000 |
| 00816818021300 | K130380 | 000 |
| 00816818020310 | K130380 | 000 |