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FDA 510(k)

SB ANCHOR

K-Number: K942889 · 1995-08-25

ApplicantOrthopaedic Biosystems, Ltd.
Decision Date1995-08-25
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SB ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Biosystems, Ltd.. It received FDA 510(k) clearance on 1995-08-25 under 510(k) number K942889. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SB ANCHOR?

SB ANCHOR is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is Orthopaedic Biosystems, Ltd.. The 510(k) number is K942889.

When did SB ANCHOR receive FDA 510(k) clearance?

SB ANCHOR received FDA 510(k) clearance on 1995-08-25, under 510(k) number K942889.

Who is the listed applicant for SB ANCHOR?

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

What is the FDA product code for SB ANCHOR?

The FDA product code for SB ANCHOR is JDR.

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Other records listing Orthopaedic Biosystems, Ltd. 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.

K000797OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01K982996POLYMER OBL SB ANCHOR / SUTURE COMBINATIONK983169POLYMER THREADED ANCHORK982963POLYMER THREADED ANCHOR / SUTURE COMBINATIONK972326PEBA ANCHOR/SUTURE COMBINATIONK963420CANCELLOUS SCREW WASHER

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Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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