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FDA 510(k)

BONE SCREW

K-Number: K893203 · 1990-04-04

ApplicantKarlin Technology, Inc.
Decision Date1990-04-04
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Karlin Technology, Inc.. It received FDA 510(k) clearance on 1990-04-04 under 510(k) number K893203. 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 BONE SCREW?

BONE SCREW is a medical device that received FDA 510(k) clearance on 1990-04-04. The listed applicant is Karlin Technology, Inc.. The 510(k) number is K893203.

When did BONE SCREW receive FDA 510(k) clearance?

BONE SCREW received FDA 510(k) clearance on 1990-04-04, under 510(k) number K893203.

Who is the listed applicant for BONE SCREW?

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

What is the FDA product code for BONE SCREW?

The FDA product code for BONE SCREW is JDR.

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Other records listing Karlin Technology, 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.

K903969SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RETK893201BONE PLATEK882525SPINAL MICROKNIFEK882519X-RAY MARKERK882073SPINAL NEEDLEK882520SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS

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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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