The following data is part of a premarket notification filed by G21 S.r.l with the FDA for G3 40 Radiopaque Bone Cement.
| Device ID | K193061 |
| 510k Number | K193061 |
| Device Name: | G3 40 Radiopaque Bone Cement |
| Classification | Bone Cement |
| Applicant | G21 S.r.l Via S. Pertini, 8 San Possidonio, IT 41039 |
| Contact | Flilippo Foroni |
| Correspondent | Barry E Sands RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-01 |
| Decision Date | 2020-03-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058964720047 | K193061 | 000 |
| 08058964729002 | K193061 | 000 |
| 08058964728739 | K193061 | 000 |
| 08058964729040 | K193061 | 000 |