The following data is part of a premarket notification filed by Orthosoft, Inc. with the FDA for Cas Fixation Pin 3.2 Dia X 180 Mm Str, Cas Fixaton Pin 3.2 Dia X 80 Mm Str, Cas Fixaton Pin 3.2 Dia X 150 Mm.
| Device ID | K100599 |
| 510k Number | K100599 |
| Device Name: | CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | ORTHOSOFT, INC. 75 QUEEN ST., SUITE 3300 Montreal, Quebec, CA H3c 2n6 |
| Contact | Christopher Mclean |
| Correspondent | Christopher Mclean ORTHOSOFT, INC. 75 QUEEN ST., SUITE 3300 Montreal, Quebec, CA H3c 2n6 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-03 |
| Decision Date | 2010-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024492684 | K100599 | 000 |
| 00889024304253 | K100599 | 000 |
| 00889024304246 | K100599 | 000 |