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FDA 510(k)

CL UNIVERSAL HIP DEVICE

K-Number: K885146 · 1989-04-24

ApplicantLima Intl. Corp.
Decision Date1989-04-24
Product CodeKWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CL UNIVERSAL HIP DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Lima Intl. Corp.. It received FDA 510(k) clearance on 1989-04-24 under 510(k) number K885146. The device is classified under product code KWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CL UNIVERSAL HIP DEVICE?

CL UNIVERSAL HIP DEVICE is a medical device that received FDA 510(k) clearance on 1989-04-24. The listed applicant is Lima Intl. Corp.. The 510(k) number is K885146.

When did CL UNIVERSAL HIP DEVICE receive FDA 510(k) clearance?

CL UNIVERSAL HIP DEVICE received FDA 510(k) clearance on 1989-04-24, under 510(k) number K885146.

Who is the listed applicant for CL UNIVERSAL HIP DEVICE?

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

What is the FDA product code for CL UNIVERSAL HIP DEVICE?

The FDA product code for CL UNIVERSAL HIP DEVICE is KWI.

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Other records listing Lima Intl. Corp. 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.

K922613CL HIP STEM H/A COATEDK910836LIMA COLLARED CL STEMK896851PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESECK900051MOORE TYPE ENDO PROSTHESISK902621SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENTK896850LIMA CERAMIC FEMORAL HEAD BIOLOX BY FELDMUEHLE

View all 8 devices →

Related Devices (Code: KWI)

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.

K260624Arthrex Radial Head Replacement SystemArthrex, Inc.K233592BioPoly Radial Head ImplantBioPoly, LLCK231188ALIGN Radial Head SystemSkeletal Dynamics, Inc.K213563DePuy Synthes Radial Head Replacement SystemDePuy SynthesK212872Avenger Radial Head SystemIn2bones USA, LLCK192754Avenger Radial Head SystemIn2bones USA, LLC

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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