The following data is part of a premarket notification filed by Calvary Spine, Llc with the FDA for Calvary Spine Pedicle Screw System.
| Device ID | K201568 |
| 510k Number | K201568 |
| Device Name: | Calvary Spine Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Calvary Spine, LLC 308 North Wind Road Towson, MD 21204 |
| Contact | James Edwards |
| Correspondent | J.d. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, UT 84401 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-11 |
| Decision Date | 2020-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B11410010 | K201568 | 000 |
| B114165500 | K201568 | 000 |
| B114165550 | K201568 | 000 |
| B114165600 | K201568 | 000 |
| B114175400 | K201568 | 000 |
| B114175450 | K201568 | 000 |
| B114175600 | K201568 | 000 |
| B114185300 | K201568 | 000 |
| B11418535 | K201568 | 000 |
| B114185500 | K201568 | 000 |
| B114165450 | K201568 | 000 |
| B114165400 | K201568 | 000 |
| B114165350 | K201568 | 000 |
| B114155250 | K201568 | 000 |
| B114155300 | K201568 | 000 |
| B114155350 | K201568 | 000 |
| B114155400 | K201568 | 000 |
| B114155450 | K201568 | 000 |
| B114155500 | K201568 | 000 |
| B114155550 | K201568 | 000 |
| B114155600 | K201568 | 000 |
| B114165300 | K201568 | 000 |
| B114185550 | K201568 | 000 |
| B114185600 | K201568 | 000 |
| B114185700 | K201568 | 000 |
| B1145800 | K201568 | 000 |
| B1145900 | K201568 | 000 |
| B11475300 | K201568 | 000 |
| B11475500 | K201568 | 000 |
| B11475550 | K201568 | 000 |
| B1148300 | K201568 | 000 |
| B1148500 | K201568 | 000 |
| B11485400 | K201568 | 000 |
| B115185450 | K201568 | 000 |
| B1145700 | K201568 | 000 |
| B1145600 | K201568 | 000 |
| B1145500 | K201568 | 000 |
| B114185800 | K201568 | 000 |
| B114185900 | K201568 | 000 |
| B11451000 | K201568 | 000 |
| B11452400 | K201568 | 000 |
| B1145300 | K201568 | 000 |
| B1145350 | K201568 | 000 |
| B1145400 | K201568 | 000 |
| B1145450 | K201568 | 000 |
| B11454800 | K201568 | 000 |
| B165350 | K201568 | 000 |