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FDA 510(k)

PRECIMED HIP SCREW SYSTEM

K-Number: K023851 · 2003-01-28

ApplicantPrecimed, Inc.
Decision Date2003-01-28
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRECIMED HIP SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Precimed, Inc.. It received FDA 510(k) clearance on 2003-01-28 under 510(k) number K023851. 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 PRECIMED HIP SCREW SYSTEM?

PRECIMED HIP SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-28. The listed applicant is Precimed, Inc.. The 510(k) number is K023851.

When did PRECIMED HIP SCREW SYSTEM receive FDA 510(k) clearance?

PRECIMED HIP SCREW SYSTEM received FDA 510(k) clearance on 2003-01-28, under 510(k) number K023851.

Who is the listed applicant for PRECIMED HIP SCREW SYSTEM?

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

What is the FDA product code for PRECIMED HIP SCREW SYSTEM?

The FDA product code for PRECIMED HIP SCREW SYSTEM is KTT.

Related Clinical Trials

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.

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Other records listing Precimed, 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.

K050754PRECIMED CANNULATED SCREW SYSTEM

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 GlobalK253202Hoffmann LRF SystemStryker GmbHK253613Monkey Rings External Ring Fixation SystemParagon 28, 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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