FDA 510(k)

C-LEG (3C100)

K-Number: K991590 · 1999-07-08

ApplicantOtto Bock Orthopedic Industry, Inc.

Decision Date1999-07-08

Product CodeISW

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

C-LEG (3C100) is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Orthopedic Industry, Inc.. It received FDA 510(k) clearance on 1999-07-08 under 510(k) number K991590. The device is classified under product code ISW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-LEG (3C100)?

C-LEG (3C100) is a medical device that received FDA 510(k) clearance on 1999-07-08. The listed applicant is Otto Bock Orthopedic Industry, Inc.. The 510(k) number is K991590.

When did C-LEG (3C100) receive FDA 510(k) clearance?

C-LEG (3C100) received FDA 510(k) clearance on 1999-07-08, under 510(k) number K991590.

Who is the listed applicant for C-LEG (3C100)?

The FDA 510(k) record lists Otto Bock Orthopedic Industry, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-LEG (3C100)?

The FDA product code for C-LEG (3C100) is ISW.

Other records listing Otto Bock Orthopedic Industry, 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.

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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.