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FDA 510(k)

APOLLO KNEE FEMORAL SPACERS

K-Number: K971770 · 1997-07-31

ApplicantSulzer Orthopedics, Inc.
Decision Date1997-07-31
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APOLLO KNEE FEMORAL SPACERS is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Orthopedics, Inc.. It received FDA 510(k) clearance on 1997-07-31 under 510(k) number K971770. 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 APOLLO KNEE FEMORAL SPACERS?

APOLLO KNEE FEMORAL SPACERS is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K971770.

When did APOLLO KNEE FEMORAL SPACERS receive FDA 510(k) clearance?

APOLLO KNEE FEMORAL SPACERS received FDA 510(k) clearance on 1997-07-31, under 510(k) number K971770.

Who is the listed applicant for APOLLO KNEE FEMORAL SPACERS?

The FDA 510(k) record lists Sulzer Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APOLLO KNEE FEMORAL SPACERS?

The FDA product code for APOLLO KNEE FEMORAL SPACERS is JWH.

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Other records listing Sulzer Orthopedics, Inc. 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.

K022985ASCENDENT ACETABULAR SYSTEMK021578NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATEK020713MS-30 LATERAL FEMORAL STEMK013935ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTSK013031MOST OPTIONS SYSTEMK012739CONVERGE ACETABULAR SYSTEM

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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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION 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.

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.

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