Integra®

Integra® Total Foot System The Forefoot and Midfoot Wires, Drills, and Drill Guide Caddy Lid is the top part of the caddy which locks onto the base and keeps content inside the base.

Registry build 21.09.26
1manufacturer
81catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OJH
Manufacturer City Province Registered as Device types
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71

Record

Regulatory record for Integra®
Listed by Ascension Orthopedics, Inc., United States
FDA product code OJH
Device type Orthopedic Tray
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Manufacturer
Premarket notification Exempt
Record published 2017-08-30
Record revised 2023-01-25 (version 10)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, expiry date
Distribution end date 2026-12-31

Catalogue Numbers

Catalogue numbers for Integra®
Catalogue number Size Status
12227009 21.15 in L x 10.62 in W x 1.69 in H In distribution
CSA-800-06 In distribution
CSA31001 In distribution
CSA00016 21.27 in L x 10.04 in W x 1.07 in H In distribution
CSA20002 In distribution
12227001 21.54 in L x 10.84 in W x 4.04 in H In distribution
CSA000010 In distribution
12227005 21.54 in L x 10.84 in W x 4.87 in H In distribution
CSA90004 In distribution
CSA-000-13 In distribution
CSA100114 10.57 in L x 9.33 in W In distribution
CSA100103 9.33 in L x 5.5 in W x.7 in H In distribution
CSA71002 In distribution
CSA100109 9.33 in L x 6.53 in W x 1.5 in H In distribution
CSA-800-07 In distribution
CSA100105 9.33 in L x 5.5 in W x 1.5 in H In distribution
CSA100116 7.3 in L x 5.32 in W x.125 in H In distribution
CSA52007 In distribution
12227008 21.15 in L x 10.62 in W x 2.48 in H In distribution
CSA100106 9.13 in L x 5.07 in W x.125 in H In distribution
CSA52006 In distribution
12227004 21.54 in L x 10.84 in W x 5.30 in H In distribution
CSA90003 In distribution
CSA20003 In distribution
17-5075T In distribution
CSA093001 In distribution
FGT-LIDT In distribution
CSA100107 6.5 in L x 5.75 in W x 2.33 in H In distribution
CSA100111 21.2 in L x 9.9 in W x 4.09 in H In distribution
CSA52005 In distribution
CSA71001 In distribution
CSA100118 9.33 in L x 7.168 in W x.125 in H In distribution
CSA85001 In distribution
CSA100108 6.3 in L x 5.32 in W x.125 in H In distribution
LMP-LIDT In distribution
CSA100101 21.2 in L x 9.8 in W x 4.03 in H In distribution
12227006 21.61 in L x 11.10 in W In distribution
CGT-LIDT In distribution
CSA89501 In distribution
12227007 21.15 in L x 10.62 in W x 1.80 in H In distribution
12227016 2.75 in L x 1.50 in W x.58 in H In distribution
CSA90001 In distribution
12227010 21.15 L x 10.62 in W x 1.69 in H In distribution
12227002 22.27 in L x 10.84 in W x 2.97 in H In distribution
CSA00004 20.66 in L x 9.91 in W In distribution
CSA-000-15 10.54 in L x 9.91 in W x.67 in H In distribution
CSA100117 9.53 in L x 7.598 in W x 1.0 in H In distribution
CSA100115 7.5 in L x 5.75 in W x 2.45 in H In distribution
17-5185T In distribution
CSA100113 11 in L x 10.6 in W x 1.0 in H In distribution
CSA85000 In distribution
CSA100104 9.13 in L x 5.07 in W x.125 in H In distribution
CSA093004 In distribution
CSA90002 In distribution
CSA093003 In distribution
CSA00001 In distribution
12227003 21.54 in L x 10.84 in W x 4.38 in H In distribution
CSA100110 9.13 in L x 6.103 in W x.125 in H In distribution
CSA35002 In distribution
CSA093002 In distribution
CSA-000-06 15.15 in L x 10.10 in W x.84 in H In distribution
17-5189T In distribution
CSA-800-03 Withdrawn
CSA-800-12 Withdrawn
CSA-800-11 Withdrawn
CSA-1006-01 10.26 in L x 9.62 in W x 1.30 in H Withdrawn
CSA-800-14 Withdrawn
CSA-800-01 Withdrawn
CSA-805-03 Withdrawn
CSA-805-01 Withdrawn
CSA-805-02 Withdrawn
CSA-800-13 Withdrawn
CSA-1006-04 6.625 in L Withdrawn
CSA-1006-02 6.625 in L Withdrawn
CSA-800-02 Withdrawn
CSA-1006-03 6.584 in L x 5.215 in W Withdrawn
CSA-000-08 Withdrawn
CSA-800-04 Withdrawn
CSA-1006-05 6.584 in L x 3.19 in W Withdrawn
CSA-805-04 Withdrawn
CSA-800-05 Withdrawn

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Showing 12 of 367. All products under Orthopedic Tray

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer