This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for non-spinal metallic bone screws and washers will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of orthopedic non-spinal metallic bone screws and washers.
Non-Spinal Metallic Bone Screw/Washer Safety and Performance Criteria
This final guidance provides performance criteria for non-metallic bone screws and washers (21 CFR 888.3040, HWC and HTN) for the Safety and Performance Based P
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