Self Retaining Soft Tissue Retractor

FDA 510(k) K101609 · Koros USA, Inc.

Substantially Equivalent

510(k) numberK101609

Submission

Device name
Self Retaining Soft Tissue Retractor
Applicant
Koros USA, Inc.
Moorepark, CA, US
Received
June 8, 2010
Decision date
December 9, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LXH – Orthopedic Manual Surgical Instrument
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

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K941896Steadman Ligament Graft Passer and ProtectorLXH · Traditional Depuy, Inc.11/07/1994SE
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K941605Stryker Femoral Canal Brush, Acetabular BrushLXH · Traditional Stryker Corp.08/05/1994SE
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Questions and answers

When was Self Retaining Soft Tissue Retractor cleared by the FDA?

Self Retaining Soft Tissue Retractor (K101609) received a 510(k) decision of Substantially Equivalent on December 9, 2010, 184 days after the submission was received.

What is the product code of K101609?

The FDA product code is LXH – Orthopedic Manual Surgical Instrument, a Class I (low risk) device regulated under 21 CFR 888.4540.