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FDA 510(k)

FRACTURE REDUCTION SYS., MODEL OR 1001

K-Number: K770388 · 1977-03-14

ApplicantSisan Assoc.
Decision Date1977-03-14
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FRACTURE REDUCTION SYS., MODEL OR 1001 is the device name listed in this FDA 510(k) record. The listed applicant is Sisan Assoc.. It received FDA 510(k) clearance on 1977-03-14 under 510(k) number K770388. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRACTURE REDUCTION SYS., MODEL OR 1001?

FRACTURE REDUCTION SYS., MODEL OR 1001 is a medical device that received FDA 510(k) clearance on 1977-03-14. The listed applicant is Sisan Assoc.. The 510(k) number is K770388.

When did FRACTURE REDUCTION SYS., MODEL OR 1001 receive FDA 510(k) clearance?

FRACTURE REDUCTION SYS., MODEL OR 1001 received FDA 510(k) clearance on 1977-03-14, under 510(k) number K770388.

Who is the listed applicant for FRACTURE REDUCTION SYS., MODEL OR 1001?

The FDA 510(k) record lists Sisan Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRACTURE REDUCTION SYS., MODEL OR 1001?

The FDA product code for FRACTURE REDUCTION SYS., MODEL OR 1001 is JEC.

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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.

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