The following data is part of a premarket notification filed by Stanmore Implants Worldwide Ltd with the FDA for Sculptor Robotic Guidance Arm (rga).
| Device ID | K121765 |
| 510k Number | K121765 |
| Device Name: | SCULPTOR ROBOTIC GUIDANCE ARM (RGA) |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | STANMORE IMPLANTS WORLDWIDE LTD 1331 H STREET, NW, 12 FLOOR Washington, DC 20005 |
| Contact | Hollace Saas Rhodes |
| Correspondent | Hollace Saas Rhodes STANMORE IMPLANTS WORLDWIDE LTD 1331 H STREET, NW, 12 FLOOR Washington, DC 20005 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2013-01-11 |
| Summary: | summary |