The following data is part of a premarket notification filed by G21 S.r.l with the FDA for G21 Spaceflex Hip.
| Device ID | K192041 |
| 510k Number | K192041 |
| Device Name: | G21 SpaceFlex Hip |
| Classification | Bone Cement, Antibiotic |
| Applicant | G21 S.r.l Via Sandro Petrini, 8 San Possidonio, IT 41039 |
| Contact | Filippo Foroni |
| Correspondent | Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite #526 Amesbury, MA 01860 |
| Product Code | MBB |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-31 |
| Decision Date | 2019-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058964726902 | K192041 | 000 |
| 08058964726896 | K192041 | 000 |
| 08058964726889 | K192041 | 000 |
| 08058964726186 | K192041 | 000 |