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FDA 510(k)

FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES

K-Number: K970257 · 1997-05-22

ApplicantFerguson Medical
Decision Date1997-05-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES is the device name listed in this FDA 510(k) record. The listed applicant is Ferguson Medical. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K970257. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES?

FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Ferguson Medical. The 510(k) number is K970257.

When did FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES receive FDA 510(k) clearance?

FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES received FDA 510(k) clearance on 1997-05-22, under 510(k) number K970257.

Who is the listed applicant for FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES?

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

What is the FDA product code for FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES?

The FDA product code for FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES is HSB.

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Other records listing Ferguson Medical as applicant

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Related Devices (Code: HSB)

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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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