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FDA 510(k)

BLADE PLATE

K-Number: K905352 · 1990-12-11

ApplicantO'Tec Corp.
Decision Date1990-12-11
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLADE PLATE is the device name listed in this FDA 510(k) record. The listed applicant is O'Tec Corp.. It received FDA 510(k) clearance on 1990-12-11 under 510(k) number K905352. 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 BLADE PLATE?

BLADE PLATE is a medical device that received FDA 510(k) clearance on 1990-12-11. The listed applicant is O'Tec Corp.. The 510(k) number is K905352.

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

BLADE PLATE received FDA 510(k) clearance on 1990-12-11, under 510(k) number K905352.

Who is the listed applicant for BLADE PLATE?

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

What is the FDA product code for BLADE PLATE?

The FDA product code for BLADE PLATE is KTT.

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Other records listing O'Tec 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.

K943293SCC22/ SCC26 SHOWER COMMODE CHAIRK910093FUTURA FEMORAL HIP STEMK905358CANCELLOUS SCREWK905355BROAD SELF-COMPRESSING PLATEK905347HAGIE PINK905357CORTICAL BONE SCREW (EUROPEAN STYLE)

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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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