The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Intramedulary Fixation Rod.
Device ID | K951740 |
510k Number | K951740 |
Device Name: | INTRAMEDULARY FIXATION ROD |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Contact | Shari L Jeffers |
Correspondent | Shari L Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-24 |
Decision Date | 1995-08-11 |