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FDA 510(k)

DIGIMATCH ROBODOC SURGICAL SYSTEM

K-Number: K072629 · 2008-08-06

ApplicantIntegrated Surgical Systems, Inc.
Decision Date2008-08-06
Product CodeOJP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DIGIMATCH ROBODOC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Surgical Systems, Inc.. It received FDA 510(k) clearance on 2008-08-06 under 510(k) number K072629. The device is classified under product code OJP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGIMATCH ROBODOC SURGICAL SYSTEM?

DIGIMATCH ROBODOC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2008-08-06. The listed applicant is Integrated Surgical Systems, Inc.. The 510(k) number is K072629.

When did DIGIMATCH ROBODOC SURGICAL SYSTEM receive FDA 510(k) clearance?

DIGIMATCH ROBODOC SURGICAL SYSTEM received FDA 510(k) clearance on 2008-08-06, under 510(k) number K072629.

Who is the listed applicant for DIGIMATCH ROBODOC SURGICAL SYSTEM?

The FDA 510(k) record lists Integrated Surgical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIGIMATCH ROBODOC SURGICAL SYSTEM?

The FDA product code for DIGIMATCH ROBODOC SURGICAL SYSTEM is OJP.

Related Clinical Trials

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Other records listing Integrated Surgical Systems, 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.

K991081FRAMELESS NEUROMATEK960685ORTHODOC PREOPERATIVE PLANNER MODEL 500

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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