FDA Cleared
Existing Device (Modification)
Pathway: 510K
Tornier Humeral Reconstruction System (HRS) Tuberosity Body
Applicant:
Tornier, Inc.
Statutory Profile
Legal Standard:
Substantial Equivalence (SE) to predicate (21 CFR 807)
Product Code:
KWS
Review Panel:
Orthopedic
21 CFR Regulation:
8
Review Velocity Metrics
Date Received:
2026-09-30
Decision Date:
2026-10-28
Total Review Duration:
28 calendar days (28 days)
Official FDA Research Backlinks
Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:
Identified Contacts & Correspondents
Rachel Zigler
Role: SUBMITTER_CONTACT
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