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FDA 510(k)

XANCHOR SUTURE ATTACHMENT DEVICE

K-Number: K932041 · 1994-08-12

ApplicantOrthopaedic Biosystems
Decision Date1994-08-12
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

XANCHOR SUTURE ATTACHMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Biosystems. It received FDA 510(k) clearance on 1994-08-12 under 510(k) number K932041. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the XANCHOR SUTURE ATTACHMENT DEVICE?

XANCHOR SUTURE ATTACHMENT DEVICE is a medical device that received FDA 510(k) clearance on 1994-08-12. The listed applicant is Orthopaedic Biosystems. The 510(k) number is K932041.

When did XANCHOR SUTURE ATTACHMENT DEVICE receive FDA 510(k) clearance?

XANCHOR SUTURE ATTACHMENT DEVICE received FDA 510(k) clearance on 1994-08-12, under 510(k) number K932041.

Who is the listed applicant for XANCHOR SUTURE ATTACHMENT DEVICE?

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

What is the FDA product code for XANCHOR SUTURE ATTACHMENT DEVICE?

The FDA product code for XANCHOR SUTURE ATTACHMENT DEVICE is JDR.

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Other records listing Orthopaedic Biosystems 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.

K922788BIOACTION LOW PROFILE SCREW SYSTEMK911552ANATOMIC TOE SYSTEM

Related Devices (Code: JDR)

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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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