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FDA 510(k)

LINK METAL-BACKED ACETABULAR CUPS

K-Number: K854935 · 1986-03-05

ApplicantLink America, Inc.
Decision Date1986-03-05
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK METAL-BACKED ACETABULAR CUPS is the device name listed in this FDA 510(k) record. The listed applicant is Link America, Inc.. It received FDA 510(k) clearance on 1986-03-05 under 510(k) number K854935. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK METAL-BACKED ACETABULAR CUPS?

LINK METAL-BACKED ACETABULAR CUPS is a medical device that received FDA 510(k) clearance on 1986-03-05. The listed applicant is Link America, Inc.. The 510(k) number is K854935.

When did LINK METAL-BACKED ACETABULAR CUPS receive FDA 510(k) clearance?

LINK METAL-BACKED ACETABULAR CUPS received FDA 510(k) clearance on 1986-03-05, under 510(k) number K854935.

Who is the listed applicant for LINK METAL-BACKED ACETABULAR CUPS?

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

What is the FDA product code for LINK METAL-BACKED ACETABULAR CUPS?

The FDA product code for LINK METAL-BACKED ACETABULAR CUPS is JDL.

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Other records listing Link America, 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.

K972760LINK, ACETABULAR REVISION MESH CUPK964458ELLIS EXTERNAL MINI-FIXATOR SYSTEMK955296LINK MP RECONSTRUCTION HIPK954186SLED UNICOMPARTMENT KNEE SYSTEMK931571LINK CERAMIC HEADS 12/14 X 32MMK931572LINK CERAMIC HEADS 14/16 X 32MM

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Related Devices (Code: JDL)

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.

K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyincK061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyincK051995PROFEMUR RENAISSANCE HIP STEMWrightmedicaltechnologyincK051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyincK042841M2A/C2A ACETABULAR SYSTEMBiomet, Inc.

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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