The following data is part of a premarket notification filed by Isotis Nv with the FDA for Acceli Dbm Family Products, 0.5cc, 1cc, 2.5cc, 5cc, 10cc, 15cc, 30cc.
| Device ID | K061880 |
| 510k Number | K061880 |
| Device Name: | ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ISOTIS NV PROF. BRONKHORSTLAAN 10-D 3723 MB Bilthoven, NL 3723 Mb |
| Contact | Elaine Schutte |
| Correspondent | Elaine Schutte ISOTIS NV PROF. BRONKHORSTLAAN 10-D 3723 MB Bilthoven, NL 3723 Mb |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2007-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981129729 | K061880 | 000 |
| M3860250001001 | K061880 | 000 |
| M3860250000501 | K061880 | 000 |
| M3860250000251 | K061880 | 000 |
| M386XPRES3251 | K061880 | 000 |
| M386XPRES3051 | K061880 | 000 |
| 10381780112549 | K061880 | 000 |
| M386XPRES1251 | K061880 | 000 |
| M386XPRES1051 | K061880 | 000 |
| M3860240005201 | K061880 | 000 |
| M3860240005501 | K061880 | 000 |
| M3860240007601 | K061880 | 000 |
| 10889981129712 | K061880 | 000 |
| M386565001001 | K061880 | 000 |
| M386565000501 | K061880 | 000 |
| M386565000251 | K061880 | 000 |
| M386563001001 | K061880 | 000 |
| M386563000501 | K061880 | 000 |
| M386563000251 | K061880 | 000 |
| M386563000101 | K061880 | 000 |
| M386XPRES1101 | K061880 | 000 |