Restoris PST
Porous Tibial Baseplate
1manufacturer
10catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Mako Surgical Corp., United States |
|---|---|
| FDA product code | NJD |
| Device type | Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3535 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K133811 |
| Record published | 2015-12-11 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 188603 | Side: Left Medial/Right Lateral | In distribution |
| 188612 | Side: Right Medial/Left Lateral | In distribution |
| 188608 | Side: Left Medial/Right Lateral | In distribution |
| 188617 | Size: 7 | In distribution |
| 188606 | Size: 6 | In distribution |
| 188614 | Size: 4 | In distribution |
| 188601 | Side: Left Medial/Right Lateral | In distribution |
| 188618 | Size: 8 | In distribution |
| 188602 | Side: Left Medial/Right Lateral | In distribution |
| 188615 | Side: Right Medial/Left Lateral | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Engage Partial Knee System | Engage Uni, LLC | 385 |
| Engage | Smith & Nephew, Inc. | 112 |
| Natural-Knee® | Zimmer, Inc. | 8 |
| Mako | Mako Surgical Corp. | 6 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133811 | 2014-07-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.