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FDA 510(k)

SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP

K-Number: K874093 · 1988-01-27

ApplicantProtek, Inc.
Decision Date1988-01-27
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Protek, Inc.. It received FDA 510(k) clearance on 1988-01-27 under 510(k) number K874093. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP?

SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1988-01-27. The listed applicant is Protek, Inc.. The 510(k) number is K874093.

When did SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP receive FDA 510(k) clearance?

SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP received FDA 510(k) clearance on 1988-01-27, under 510(k) number K874093.

Who is the listed applicant for SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP?

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

What is the FDA product code for SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP?

The FDA product code for SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP is JDI.

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Other records listing Protek, 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.

K893785ARC-2F ACETABULAR CUPK893959P.S.A. FEMORAL HIP PROSTHESISK892059FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SURK883794RESUBMITTED CLW ACETABULAR CUP W/SULMESHK884952VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMICK884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.

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Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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