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FDA 510(k)

ODI COMPRESSION HIP SCREW SYSTEM

K-Number: K971993 · 1997-11-12

ApplicantOrthopaedic Designs, Inc.
Decision Date1997-11-12
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ODI COMPRESSION HIP SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Designs, Inc.. It received FDA 510(k) clearance on 1997-11-12 under 510(k) number K971993. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODI COMPRESSION HIP SCREW SYSTEM?

ODI COMPRESSION HIP SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-12. The listed applicant is Orthopaedic Designs, Inc.. The 510(k) number is K971993.

When did ODI COMPRESSION HIP SCREW SYSTEM receive FDA 510(k) clearance?

ODI COMPRESSION HIP SCREW SYSTEM received FDA 510(k) clearance on 1997-11-12, under 510(k) number K971993.

Who is the listed applicant for ODI COMPRESSION HIP SCREW SYSTEM?

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

What is the FDA product code for ODI COMPRESSION HIP SCREW SYSTEM?

The FDA product code for ODI COMPRESSION HIP SCREW SYSTEM is KTT.

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Other records listing Orthopaedic Designs, 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.

K880737SELF GUIDING (SG) INTERLOCKING NAIL

Related Devices (Code: KTT)

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.

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