FDA applicant
Sulzer Orthopedics, Inc.
FDA records 45 decisions for Sulzer Orthopedics, Inc. (Austin, TX) from 1997 to 2002: 45 510(k) clearances. Most are in product codes LPH (Prosthesis, Hip, Semi-Constrained…) and LZO (Prosthesis, Hip, Semi-Constrained…). Its devices cite 3 predicates, 2 of them its own earlier devices. 25 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sulzer Orthopedics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Sulzer Orthopedics, Inc. since 2007.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Sulzer Orthopedics, 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 “Sulzer”
FDA records each applicant name separately; these may or may not be the same firm.