The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Orthoblast Ii Putty And Paste.
| Device ID | K050642 |
| 510k Number | K050642 |
| Device Name: | ORTHOBLAST II PUTTY AND PASTE |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Contact | Paul Doner |
| Correspondent | Paul Doner ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE B Irvine, CA 92618 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-11 |
| Decision Date | 2005-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M386562301001 | K050642 | 000 |
| M386TXCPA031 | K050642 | 000 |
| M386TXCPA081 | K050642 | 000 |
| M386TXCPY051 | K050642 | 000 |
| M386TXCPY101 | K050642 | 000 |
| M386562200101 | K050642 | 000 |
| M386562200301 | K050642 | 000 |
| M386562200801 | K050642 | 000 |
| M386562300501 | K050642 | 000 |
| M386TXCPA011 | K050642 | 000 |