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Orthopedic Packs

by Sterile Concepts, Inc.

510(k) K951231

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK951231 Date1 Dec 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
GAN
Device Class
Class II
Regulation
21 CFR Part 878.4830
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

Orthopedic Packs are sterile, pre-assembled surgical kits designed for orthopedic procedures. These packs contain essential drapes and supplies tailored to maintain aseptic conditions during surgical interventions in orthopedic surgery, including general and plastic surgery applications.

The packs are supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K951231) under regulation number 878.4830. They are classified as Class II devices and are distributed in various configurations, as indicated by the associated product codes (GAN). No additional regulatory status beyond the stated FDA clearance is implied.

Other devices from Sterile Concepts, Inc.

See all devices from Sterile Concepts, Inc. →

Questions

AI-generated answers, 19 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 are Orthopedic Packs used for?

    Orthopedic Packs are sterile, pre-assembled surgical kits designed for orthopedic procedures, including general and plastic surgery applications, to maintain aseptic conditions during surgical interventions.

  • How are Orthopedic Packs supplied?

    The packs are supplied sterile and intended for single-use, with various configurations available as indicated by the associated product codes (GAN).

  • What is the regulatory status of Orthopedic Packs?

    Orthopedic Packs have FDA 510(k) clearance (K951231) under regulation number 878.4830 and are classified as Class II devices.

  • Are Orthopedic Packs reusable?

    No, Orthopedic Packs are intended for single-use only and should not be reused due to their sterile nature and design for one-time surgical procedures.