Specials

Offset Lipped Posterior Retractor Blade, 100mm

Registry build 21.09.26
34manufacturers in China registered for this device type
78catalogue numbers in this listing
2recalls on this code

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 Specials
Listed by Seaspine Orthopedics Corporation, United States
FDA product code GAD
Device type Retractor
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-03-24
Record revised 2025-10-24 (version 4)

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

Catalogue Numbers

Catalogue numbers for Specials
Catalogue number Size Status
SR-1017-80 In distribution
SR-1359-160 In distribution
SR-0629 In distribution
SR-0736-08 In distribution
SR-1485 In distribution
SR-0533 In distribution
SR-1217-35 In distribution
SR-1217-50 In distribution
SR-1468-050 In distribution
SR-1201-75 In distribution
SR-0892 In distribution
SR-0669-140 In distribution
SR-1380-75 In distribution
SR-0669-160 In distribution
SR-0669-150 In distribution
SR-1328-70 In distribution
SR-1359-120 In distribution
SR-1358-1180 In distribution
SR-1201-35 In distribution
SR-1359-140 In distribution
SR-1359-100 In distribution
SR-0670-150 In distribution
SR-0670-130 In distribution
SR-0670-160 In distribution
SR-1519 In distribution
SR-0670-120 In distribution
SR-1468-075 In distribution
SR-0358 In distribution
SR-0659 In distribution
SR-1328-50 In distribution
SR-0737-08 In distribution
SR-1018-60 In distribution
SR-1380-35 In distribution
SR-0670-140 In distribution
SR-0535 In distribution
SR-1468-035 In distribution
SR-0371 In distribution
SR-0528-02 In distribution
SR-1358-1100 In distribution
SR-0528-03 In distribution
SR-1375-150 In distribution
SR-1018-40 In distribution
SR-1375-180 In distribution
SR-1002-05 In distribution
SR-1017-70 In distribution
SR-1359-180 In distribution
SR-0730 In distribution
SR-1017-60 In distribution
SR-0669-120 In distribution
SR-0736-10 In distribution
SR-1380-50 In distribution
SR-1358-1150 In distribution
SR-1017-40 In distribution
SR-1328-80 In distribution
SR-1217-75 In distribution
SR-0370 In distribution
SR-0669-130 In distribution
SR-1201-50 In distribution
SR-1486 In distribution
SR-0452 In distribution
SR-1328-60 In distribution
SR-1358-2100 In distribution
SR-0528-01 In distribution
SR-1354 In distribution
SR-0736-09 In distribution
SR-1017-50 In distribution
SR-1358-2150 In distribution
SR-0768 In distribution
SR-1002-10 In distribution
SR-1018-80 In distribution
SR-1002-07 In distribution
SR-1018-70 In distribution
SR-1358-2180 In distribution
SR-1018-50 In distribution
SR-0738-09 In distribution
SR-0736-07 In distribution
SR-1218 In distribution
SR-0510 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

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity
2024-05-17 Class II Under Investigation by firm Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure 21 units
2024-05-17 Class II Under Investigation by firm Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure 31 units

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