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FDA 510(k)

ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

K-Number: K082095 · 2008-10-21

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date2008-10-21
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 2008-10-21 under 510(k) number K082095. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE?

ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE is a medical device that received FDA 510(k) clearance on 2008-10-21. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K082095.

When did ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE receive FDA 510(k) clearance?

ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE received FDA 510(k) clearance on 2008-10-21, under 510(k) number K082095.

Who is the listed applicant for ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE?

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

What is the FDA product code for ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE?

The FDA product code for ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE is HTN.

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Other records listing Smith & Nephew Endoscopy, 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.

K103309OSTEORAPTOR CURVED 2.3 SUTURE ANCHORSK102660BIORAPTOR CURVED 2.3 PK SUTURE ANCHORSK093428SMITH & NEPHEW KNOTLESS INSTABILITY ANCHORK083226SMITH & NEPHEW PEEK INTERFERENCE SCREWK083635SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREWK050580SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS

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Related Devices (Code: HTN)

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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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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