The following data is part of a premarket notification filed by Orthocon, Llc with the FDA for Orthocon Llc Orthostat Hemostatic Bone Putty.
| Device ID | K043260 |
| 510k Number | K043260 |
| Device Name: | ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY |
| Classification | Wax, Bone |
| Applicant | ORTHOCON, LLC 167 STONE HILL ROAD Colts Neck, NY |
| Contact | Howard Schrayer |
| Correspondent | Howard Schrayer ORTHOCON, LLC 167 STONE HILL ROAD Colts Neck, NY |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2004-11-24 |
| Decision Date | 2005-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850391007160 | K043260 | 000 |
| 00850391007030 | K043260 | 000 |
| 00850391007153 | K043260 | 000 |