The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acumed Bone Graft System.
| Device ID | K960711 |
| 510k Number | K960711 |
| Device Name: | ACUMED BONE GRAFT SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Shari L Jeffers |
| Correspondent | Shari L Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-21 |
| Decision Date | 1996-05-07 |
| Summary: | summary |