Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SpaceFix Shoulder Spacer

K-Number: K252443 · 2025-09-15

ApplicantG21, S.R.L.
Decision Date2025-09-15
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SpaceFix Shoulder Spacer is the device name listed in this FDA 510(k) record. The listed applicant is G21, S.R.L.. It received FDA 510(k) clearance on 2025-09-15 under 510(k) number K252443. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpaceFix Shoulder Spacer?

SpaceFix Shoulder Spacer is a medical device that received FDA 510(k) clearance on 2025-09-15. The listed applicant is G21, S.R.L.. The 510(k) number is K252443.

When did SpaceFix Shoulder Spacer receive FDA 510(k) clearance?

SpaceFix Shoulder Spacer received FDA 510(k) clearance on 2025-09-15, under 510(k) number K252443.

Who is the listed applicant for SpaceFix Shoulder Spacer?

The FDA 510(k) record lists G21, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpaceFix Shoulder Spacer?

The FDA product code for SpaceFix Shoulder Spacer is MBB.

Other records listing G21, S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223441SpaceFlex Acetabular CupK202338SpaceFlex ShoulderK201960SpaceFlex Knee - 80mm SizeK193061G3 40 Radiopaque Bone CementK193059G1 40 Radiopaque Bone CementK192041G21 SpaceFlex Hip

View all 11 devices →

Related Devices (Code: MBB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242216GENTAFIX® (1, 3, 3MV)Teknimed SasK240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbHK222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.K213287StageOne Knee Cement Spacer MoldsBiomet, Inc.K202338SpaceFlex ShoulderG21, S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑