The following data is part of a premarket notification filed by I.t.s. Gmbh with the FDA for I.t.s. Pelvic Reconstruction System (prs Rx & Prs Phoenix).
| Device ID | K210935 |
| 510k Number | K210935 |
| Device Name: | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) |
| Classification | Plate, Fixation, Bone |
| Applicant | I.T.S. GmbH Autal 28 Lassnitzhoehe, AT 8301 |
| Contact | Florian Grill |
| Correspondent | Jennifer Hadfield Qserve Group, US, Inc. 350 S Main Street, Suite 309 Doylestown, PA 18901 |
| Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-29 |
| Decision Date | 2022-08-31 |