The following data is part of a premarket notification filed by Weigao Orthopaedic Device Co., Ltd with the FDA for Milestone Spinal System.
| Device ID | K133053 |
| 510k Number | K133053 |
| Device Name: | MILESTONE SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | WEIGAO ORTHOPAEDIC DEVICE CO., LTD PO BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WEIGAO ORTHOPAEDIC DEVICE CO., LTD PO BOX 120-119 Shanghai, CN 200120 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2014-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06939488383692 | K133053 | 000 |
| 06939488383524 | K133053 | 000 |
| 06939488383517 | K133053 | 000 |
| 06912547325383 | K133053 | 000 |
| 06912547325376 | K133053 | 000 |
| 06912547325369 | K133053 | 000 |
| 06912547325352 | K133053 | 000 |
| 06912547325345 | K133053 | 000 |
| 06912547325338 | K133053 | 000 |
| 06912547325321 | K133053 | 000 |
| 06912547325314 | K133053 | 000 |
| 06912547325307 | K133053 | 000 |
| 06912547325291 | K133053 | 000 |
| 06912547325284 | K133053 | 000 |
| 06939488383531 | K133053 | 000 |
| 06939488383548 | K133053 | 000 |
| 06939488383555 | K133053 | 000 |
| 06939488383685 | K133053 | 000 |
| 06939488383678 | K133053 | 000 |
| 06939488383661 | K133053 | 000 |
| 06939488383654 | K133053 | 000 |
| 06939488383647 | K133053 | 000 |
| 06939488383630 | K133053 | 000 |
| 06939488383623 | K133053 | 000 |
| 06939488383616 | K133053 | 000 |
| 06939488383609 | K133053 | 000 |
| 06939488383593 | K133053 | 000 |
| 06939488383586 | K133053 | 000 |
| 06939488383579 | K133053 | 000 |
| 06939488383562 | K133053 | 000 |
| 06912547325277 | K133053 | 000 |