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FDA 510(k)

GSPE Spacer

K-Number: K260063 · 2026-09-11

ApplicantThe General Hospital Corporation, d/b/a Massachusetts
Decision Date2026-09-11
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GSPE Spacer is the device name listed in this FDA 510(k) record. The listed applicant is The General Hospital Corporation, d/b/a Massachusetts. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K260063. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSPE Spacer?

GSPE Spacer is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is The General Hospital Corporation, d/b/a Massachusetts. The 510(k) number is K260063.

When did GSPE Spacer receive FDA 510(k) clearance?

GSPE Spacer received FDA 510(k) clearance on 2026-09-11, under 510(k) number K260063.

Who is the listed applicant for GSPE Spacer?

The FDA 510(k) record lists The General Hospital Corporation, d/b/a Massachusetts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSPE Spacer?

The FDA product code for GSPE Spacer is JWH.

Related Devices (Code: JWH)

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.

K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.

Official Source

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

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