510(k) Report

Devices descending from K152267

2 later devices reach Remedy® Shoulder Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+1K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—