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FDA 510(k)

PREMIER-TOTAL HIP

K-Number: K894051 · 1989-08-28

ApplicantIntermedics Orthopedics
Decision Date1989-08-28
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PREMIER-TOTAL HIP is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1989-08-28 under 510(k) number K894051. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER-TOTAL HIP?

PREMIER-TOTAL HIP is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Intermedics Orthopedics. The 510(k) number is K894051.

When did PREMIER-TOTAL HIP receive FDA 510(k) clearance?

PREMIER-TOTAL HIP received FDA 510(k) clearance on 1989-08-28, under 510(k) number K894051.

Who is the listed applicant for PREMIER-TOTAL HIP?

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

What is the FDA product code for PREMIER-TOTAL HIP?

The FDA product code for PREMIER-TOTAL HIP is LWJ.

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Other records listing Intermedics Orthopedics 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.

K970300NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTIK970498NATURAL-KNEE II REVISION FEMORAL SPACER LUGSK970166NATURAL-HIP SYSTEM COCR REVISION STEMK970567SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDSK964357NATURAL-HIP SYSTEM COCR STEMK964350MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA

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Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K082146METHA SHORT STEM HIP SYSTEM XL FEMORAL HEADAesculap Implant Systems, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.

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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