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FDA 510(k)

DAY STAPLE

K-Number: K853267 · 1985-09-06

ApplicantProtek, Inc.
Decision Date1985-09-06
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

DAY STAPLE is the device name listed in this FDA 510(k) record. The listed applicant is Protek, Inc.. It received FDA 510(k) clearance on 1985-09-06 under 510(k) number K853267. 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 DAY STAPLE?

DAY STAPLE is a medical device that received FDA 510(k) clearance on 1985-09-06. The listed applicant is Protek, Inc.. The 510(k) number is K853267.

When did DAY STAPLE receive FDA 510(k) clearance?

DAY STAPLE received FDA 510(k) clearance on 1985-09-06, under 510(k) number K853267.

Who is the listed applicant for DAY STAPLE?

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

What is the FDA product code for DAY STAPLE?

The FDA product code for DAY STAPLE is JDR.

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Other records listing Protek, 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.

K893785ARC-2F ACETABULAR CUPK893959P.S.A. FEMORAL HIP PROSTHESISK892059FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SURK883794RESUBMITTED CLW ACETABULAR CUP W/SULMESHK884952VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMICK884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.

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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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