The following data is part of a premarket notification filed by G21 S.r.l with the FDA for Spaceflex Knee - 80mm Size.
| Device ID | K201960 |
| 510k Number | K201960 |
| Device Name: | SpaceFlex Knee - 80mm Size |
| 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 01913 |
| Product Code | MBB |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-14 |
| Decision Date | 2020-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058964727039 | K201960 | 000 |