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FDA 510(k)

SURGICAL DYNAMICS SPINAL RETRACTOR

K-Number: K002008 · 2000-08-16

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date2000-08-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURGICAL DYNAMICS SPINAL RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 2000-08-16 under 510(k) number K002008. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL DYNAMICS SPINAL RETRACTOR?

SURGICAL DYNAMICS SPINAL RETRACTOR is a medical device that received FDA 510(k) clearance on 2000-08-16. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K002008.

When did SURGICAL DYNAMICS SPINAL RETRACTOR receive FDA 510(k) clearance?

SURGICAL DYNAMICS SPINAL RETRACTOR received FDA 510(k) clearance on 2000-08-16, under 510(k) number K002008.

Who is the listed applicant for SURGICAL DYNAMICS SPINAL RETRACTOR?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL DYNAMICS SPINAL RETRACTOR?

The FDA product code for SURGICAL DYNAMICS SPINAL RETRACTOR is HRX.

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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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