FDA applicant
Synergy Orthopaedics Intl., Inc.
FDA records 2 decisions for Synergy Orthopaedics Intl., Inc. (Indianapolis, IN) from 1989 to 1990: 2 510(k) clearances. Most are in product codes JDL (Prosthesis, Hip, Semi-Constrained (Metal…) and KWA (Prosthesis, Hip, Semi-Constrained (Metal…). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Synergy Orthopaedics Intl., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Synergy Orthopaedics Intl., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Synergy Orthopaedics Intl., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Synergy”
FDA records each applicant name separately; these may or may not be the same firm.