Integra®

Integra®Surgical Instruments The Kolbel retractor frame is the base of the retractor, in which different size blades are attached. The retractor is used to withdraw muscle and tissue for…

Registry build 21.09.26

Integra®Surgical Instruments The Kolbel retractor frame is the base of the retractor, in which different size blades are attached. The retractor is used to withdraw muscle and tissue for exposure.

34manufacturers in China registered for this device type
22catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GAD
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Microport Orthorecon Co., Ltd. Suzhou Jiangsu Contract manufacturer 31
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74

Showing 12 of 34. All 34 manufacturers in China registered for Retractor

Record

Regulatory record for Integra®
Listed by Ascension Orthopedics, Inc., United States
FDA product code GAD
Device type Retractor
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Manufacturer
Premarket notification Exempt
Record published 2017-09-29
Record revised 2023-01-25 (version 6)

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
Distribution end date 2026-12-31

Catalogue Numbers

Catalogue numbers for Integra®
Catalogue number Size Status
RET92060XL X-Large In distribution
RET92061XL X-Large In distribution
RET92010S Size 01; 10.7 in L x.50 in W In distribution
RET-920-20 10.9 in L x 2.8 in W In distribution
RET92061S Small In distribution
RTKTFS01 76 mm L x 51 mm W In distribution
RET-920-31 8.9 in L x 4.5 in W In distribution
RET-920-11L Size 02; 10.7 in L x.75 in W In distribution
RET92030 8.9 in L x 4.5 in W In distribution
RET92060S Small In distribution
RET-920-11S Size 01; 10.7 in L x.50 in W In distribution
RET92010L Size 02; 10.7 in L x.75 in W In distribution
RET-920-50L Size 02- Large; 1.5 in W caliper In distribution
RET-920-41L Size 02; Large In distribution
RET-920-41S Size 01; Small In distribution
RET-920-60 Sm
Md
Lg
In distribution
RET92040S Size 01; Small In distribution
RET92040L Size 02; Large In distribution
RET-920-50S Size 01- Small; 1.25 in W caliper In distribution
RET92061L Large In distribution
RET92060L Large In distribution
RET90001 8.86 in L x 4.5 in W In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Thompson Thompson Surgical Instruments, Inc. 4,354
Millennium Avalign Technologies, Inc. 2,128
Surtex Surtex Instruments Ltd 1,318
Life Instruments Life Instrument Corp. 1,135
Innomed, Inc. Innomed, Inc. 1,017
Aesculap Aesculap AG 1,013
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 973
Elmed Elmed, Inc. 919
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 891
Boss Instruments Boss Instruments, Ltd. 799
gSource Gsource, LLC. 753
Sklar® Sklar Corporation 753

Showing 12 of 2,238. All products under Retractor

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