The following data is part of a premarket notification filed by G21 Srl with the FDA for Spaceflex Shoulder.
| Device ID | K202338 |
| 510k Number | K202338 |
| Device Name: | SpaceFlex Shoulder |
| Classification | Bone Cement, Antibiotic |
| Applicant | G21 Srl Via Sandro Pertini, 8 San Possidonio, IT 41039 |
| Contact | Filippo Foroni |
| Correspondent | Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 |
| Product Code | MBB |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-17 |
| Decision Date | 2021-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058964726087 | K202338 | 000 |
| 08058964729088 | K202338 | 000 |
| 08058964729095 | K202338 | 000 |
| 08058964729118 | K202338 | 000 |
| 08058964729125 | K202338 | 000 |
| 08058964729132 | K202338 | 000 |
| 08058964729149 | K202338 | 000 |
| 08058964728807 | K202338 | 000 |
| 08058964728814 | K202338 | 000 |
| 08058964728821 | K202338 | 000 |
| 08058964728869 | K202338 | 000 |
| 08058964728661 | K202338 | 000 |
| 08058964728777 | K202338 | 000 |
| 08058964724977 | K202338 | 000 |
| 08058964726049 | K202338 | 000 |
| 08058964726056 | K202338 | 000 |
| 08058964726063 | K202338 | 000 |
| 08058964726070 | K202338 | 000 |
| 08058964726797 | K202338 | 000 |