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FDA 510(k)

LINK GIEBEL BLADE PLATE SYSTEM

K-Number: K895507 · 1990-03-13

ApplicantLink America, Inc.
Decision Date1990-03-13
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK GIEBEL BLADE PLATE SYSTEM 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 1990-03-13 under 510(k) number K895507. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK GIEBEL BLADE PLATE SYSTEM?

LINK GIEBEL BLADE PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 1990-03-13. The listed applicant is Link America, Inc.. The 510(k) number is K895507.

When did LINK GIEBEL BLADE PLATE SYSTEM receive FDA 510(k) clearance?

LINK GIEBEL BLADE PLATE SYSTEM received FDA 510(k) clearance on 1990-03-13, under 510(k) number K895507.

Who is the listed applicant for LINK GIEBEL BLADE PLATE SYSTEM?

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 GIEBEL BLADE PLATE SYSTEM?

The FDA product code for LINK GIEBEL BLADE PLATE SYSTEM is KTT.

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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: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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