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FDA 510(k)

REPROCESSED EXTERNAL FIXATION DEVICE

K-Number: K061759 · 2006-09-05

ApplicantAscent Healthcare Solutions
Decision Date2006-09-05
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REPROCESSED EXTERNAL FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ascent Healthcare Solutions. It received FDA 510(k) clearance on 2006-09-05 under 510(k) number K061759. 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 REPROCESSED EXTERNAL FIXATION DEVICE?

REPROCESSED EXTERNAL FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 2006-09-05. The listed applicant is Ascent Healthcare Solutions. The 510(k) number is K061759.

When did REPROCESSED EXTERNAL FIXATION DEVICE receive FDA 510(k) clearance?

REPROCESSED EXTERNAL FIXATION DEVICE received FDA 510(k) clearance on 2006-09-05, under 510(k) number K061759.

Who is the listed applicant for REPROCESSED EXTERNAL FIXATION DEVICE?

The FDA 510(k) record lists Ascent Healthcare Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED EXTERNAL FIXATION DEVICE?

The FDA product code for REPROCESSED EXTERNAL FIXATION DEVICE is KTT.

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Other records listing Ascent Healthcare Solutions 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.

K111600REPROCESSED HAND ACTIVATE SEALER/DIVIDERK110189REPROCESSED ELECTROSURGICAL INSTRUMENTK100909REPROCESSED COMPRESSION SLEEVESK100254REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERK100537REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUEK100080REPROCESSED TROCARS, MODEL B5LT AND CB5LT

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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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