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Day Staple

by Protek, Inc.

510(k) K853267

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK853267 Date6 Sep 1985DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JDR
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Day Staple is a bone fixation staple used in orthopedic procedures. It is designed to provide stabilization and fixation for bone segments.

This device is classified as an FDA class 2 medical device under regulation 888.3030. It received FDA 510(k) clearance on September 6, 1985, under the K853267 submission.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical use of the Day Staple?

    The Day Staple is indicated for use in orthopedic procedures to provide stabilization and fixation for bone segments, helping to maintain the alignment of bone during the healing process.

  • What is the regulatory status of this device?

    The Day Staple is classified as an FDA class 2 medical device under regulation 888.3030. It received FDA 510(k) clearance on September 6, 1985, under submission number K853267.

  • Who is the manufacturer of the Day Staple?

    The Day Staple is manufactured by Protek, Inc., which is based in Indianapolis, Indiana.