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FDA 510(k)

LATERAL PIVOT INSERT

K-Number: K000590 · 2000-05-11

ApplicantEncore Orthopedics, Inc.
Decision Date2000-05-11
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LATERAL PIVOT INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 2000-05-11 under 510(k) number K000590. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATERAL PIVOT INSERT?

LATERAL PIVOT INSERT is a medical device that received FDA 510(k) clearance on 2000-05-11. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K000590.

When did LATERAL PIVOT INSERT receive FDA 510(k) clearance?

LATERAL PIVOT INSERT received FDA 510(k) clearance on 2000-05-11, under 510(k) number K000590.

Who is the listed applicant for LATERAL PIVOT INSERT?

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

What is the FDA product code for LATERAL PIVOT INSERT?

The FDA product code for LATERAL PIVOT INSERT is JWH.

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Other records listing Encore Orthopedics, Inc. as applicant

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Related Devices (Code: JWH)

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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