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FDA 510(k)

R&R EXTERNAL FIXATION SYSTEM

K-Number: K052005 · 2005-09-06

ApplicantR&R Medical, Inc.
Decision Date2005-09-06
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

R&R EXTERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is R&R Medical, Inc.. It received FDA 510(k) clearance on 2005-09-06 under 510(k) number K052005. 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 R&R EXTERNAL FIXATION SYSTEM?

R&R EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-06. The listed applicant is R&R Medical, Inc.. The 510(k) number is K052005.

When did R&R EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

R&R EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 2005-09-06, under 510(k) number K052005.

Who is the listed applicant for R&R EXTERNAL FIXATION SYSTEM?

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

What is the FDA product code for R&R EXTERNAL FIXATION SYSTEM?

The FDA product code for R&R EXTERNAL FIXATION 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 R&R Medical, 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.

K043174STEALTH FUSION SYSTEM, MODEL RR 1000

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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