The following data is part of a premarket notification filed by G21 S.r.l with the FDA for Spaceflex Knee.
| Device ID | K190216 |
| 510k Number | K190216 |
| Device Name: | SpaceFlex Knee |
| Classification | Bone Cement, Antibiotic |
| Applicant | G21 S.R.L Via Sandro Petrini, 8 San Possidonio, IT 41039 |
| Contact | Filippo Foroni |
| Correspondent | Manjusha Bharadwaj RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 |
| Product Code | MBB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-04 |
| Decision Date | 2019-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058964726940 | K190216 | 000 |
| 08058964726933 | K190216 | 000 |