The following data is part of a premarket notification filed by Johnson & Johnson International with the FDA for Orthosorb(r) Absorbable Pin.
Device ID | K901456 |
510k Number | K901456 |
Device Name: | ORTHOSORB(R) ABSORBABLE PIN |
Classification | Pin, Fixation, Resorbable, Hard Tissue |
Applicant | JOHNSON & JOHNSON INTERNATIONAL 100 BAY STATE DR. Braintree, MA 02184 |
Contact | Marsha J Stone |
Correspondent | Marsha J Stone JOHNSON & JOHNSON INTERNATIONAL 100 BAY STATE DR. Braintree, MA 02184 |
Product Code | OVZ |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-27 |
Decision Date | 1990-08-15 |