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 |