FDA device listing
CeMend 10-42 mold insert press,CeMend 10-48 mold insert press,CeMend 12-42 mold insert press,CeMend 12-48 mold insert…
FDA device listing 1103230002 · G21 s.r.l.
Key facts
| Proprietary names | CeMend 10-42 mold insert press,CeMend 10-48 mold insert press,CeMend 12-42 mold insert press,CeMend 12-48 mold insert press,CeMend 14-48 mold insert press,CeMend 42mm head insert,CeMend 48mm head insert,CeMend 8-42 mold insert press,CeMend Base Compression Bolt,CeMend Core Extension,CeMend Mold Base,CeMend Shoulder Mold Tray,CeMend Shoulder Spacer Mold,SpaceFlex Shoulder,SpaceFlex Shoulder Core… |
|---|---|
| Owner/operator | G21 s.r.l. |
| Owner/operator number | 10051231 |
| Premarket submissions | K202338 |
| Product codes | HSD, KWS, MBB |
| Device names | HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, MBB - Bone Cement, Antibiotic |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3027, 888.3660, 888.3690 |
| Review panels | Orthopedic |
| Registered establishments | G21 S.R.I. |
| Establishment registrations | 3010898856 |
| FEI numbers | 3010898856 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database