Submission Details
| 510(k) Number | K093433 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 04, 2009 |
| Decision Date | January 28, 2010 |
| Days to Decision | 85 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Special
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
Jan 2010
Decision
85d
Days
Class 2
Risk
About This 510(k) Submission
K093433 is an FDA 510(k) clearance for the VARIAX ELBOW SYSTEM PLATE LINE EXTENSION, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on January 28, 2010, 85 days after receiving the submission on November 4, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.
Device Classification
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
Manufacturer
Similar Devices — HRS Plate, Fixation, Bone
All 1291
K253906 · Newclip Technics
· Mar 2026
K260069 · Synthes GmbH
· Mar 2026
K260353 · Arthrex, Inc.
· Mar 2026
K254054 · Synthes GmbH
· Mar 2026
K254249 · Hankil Tech Medical Co., Ltd.
· Feb 2026
K252166 · Globus Medical, Inc.
· Feb 2026
More from Howmedica Osteonics Corp.
View all
K193429
· JDI · Aug 2020
K200782
· MBH · May 2020
K130895
· PHX · Dec 2013
K123604
· MAY · Aug 2013
K122015
· KRO · Feb 2013