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FDA 510(k)

ENSPLINTCMX CLAVICLE PIN

K-Number: K081832 · 2008-10-10

ApplicantSonoma Orthopedic Products, Inc.
Decision Date2008-10-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENSPLINTCMX CLAVICLE PIN is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Orthopedic Products, Inc.. It received FDA 510(k) clearance on 2008-10-10 under 510(k) number K081832. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENSPLINTCMX CLAVICLE PIN?

ENSPLINTCMX CLAVICLE PIN is a medical device that received FDA 510(k) clearance on 2008-10-10. The listed applicant is Sonoma Orthopedic Products, Inc.. The 510(k) number is K081832.

When did ENSPLINTCMX CLAVICLE PIN receive FDA 510(k) clearance?

ENSPLINTCMX CLAVICLE PIN received FDA 510(k) clearance on 2008-10-10, under 510(k) number K081832.

Who is the listed applicant for ENSPLINTCMX CLAVICLE PIN?

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

What is the FDA product code for ENSPLINTCMX CLAVICLE PIN?

The FDA product code for ENSPLINTCMX CLAVICLE PIN is HSB.

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Other records listing Sonoma Orthopedic Products, 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.

K161371Sonoma Fifth Metatarsal Repair SystemK111550SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)K100112SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)K092110WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)K090304WAVEON WRX BONE FIXATION SYSTEMK080778ENSPLINT TM BONE SCREW

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Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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