Symmetry Karlin™

Karlin Cutter, Xl Cervical Microdiscetomy Bone Cutter, Forward Angle, 4 1/10 in Working Length, 9 1/2 in, 241 mm

Registry build 21.09.26
4manufacturers in China registered for this device type
61catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (2), Shandong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FZS
Manufacturer City Province Registered as Device types
Shanghai KiNETIC Medical Co Ltd Shanghai Shanghai Contract manufacturer 19
Jiangsu Ideal Medical Science & Technology Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222

Record

Regulatory record for Symmetry Karlin™
Listed by Aspen Surgical Products, Inc., United States
FDA product code FZS
Device type Curette, Surgical, General Use
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-09-20
Record revised 2025-10-29 (version 5)

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, manufacturing date
Sizes Length 8.5 to 13.25 in; width 0.6 in
Distribution end date 2024-10-08
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Symmetry Karlin™
Catalogue number Size Status
46-3120 In distribution
46-3136 Length 9.5 in In distribution
46-3162 Length 8.5 in In distribution
46-3159 Length 8.5 in In distribution
46-2637 Length 9.5 in In distribution
46-2625 In distribution
46-2629 Length 9.5 in In distribution
46-2641 Length 9.5 in In distribution
46-3160 Length 8.5 in In distribution
46-3126 Length 9.5 in In distribution
46-3154 Length 8.5 in In distribution
46-3137 Length 9.5 in In distribution
46-3138 Length 9.5 in In distribution
46-3134 Length 9.5 in In distribution
46-3121 Length 9.5 in In distribution
46-3161 Length 8.5 in In distribution
46-2630 Length 9.5 in In distribution
46-2631 Length 9.5 in In distribution
46-3152 Length 8.5 in In distribution
46-3170 Length 8.5 in In distribution
46-3129 Length 9.5 in In distribution
46-3163 Length 8.5 in In distribution
46-3131 Length 9.5 in In distribution
46-3128 Length 9.5 in In distribution
46-2647 In distribution
46-3168 Length 8.5 in In distribution
46-3130 Length 9.5 in In distribution
46-3158 Length 8.5 in In distribution
46-2633 Length 9.5 in In distribution
46-3164 Length 8.5 in In distribution
46-3157 Length 8.5 in In distribution
46-3169 Length 8.5 in In distribution
46-3132 Length 9.5 in In distribution
46-2639 Length 9.5 in In distribution
46-2646 Length 9.5 in In distribution
46-3167 Length 8.5 in In distribution
46-2640 Length 9.5 in In distribution
46-2636 Length 9.5 in In distribution
46-2645 Length 9.5 in In distribution
46-2643 Length 9.5 in In distribution
46-2626 Length 9.5 in In distribution
46-3153 Length 8.5 in In distribution
46-3151 Length 8.5 in In distribution
46-2632 Length 9.5 in In distribution
46-3127 Length 9.5 in In distribution
46-3122 Length 9.5 in In distribution
46-3165 Length 8.5 in In distribution
46-3150 In distribution
46-3135 Length 9.5 in In distribution
46-3123 Length 9.5 in In distribution
46-3166 Length 8.5 in In distribution
46-2644 Length 9.5 in In distribution
46-3124 Length 9.5 in In distribution
46-2635 Length 9.5 in In distribution
46-3221 10 mm Diameter In distribution
46-2642 Length 9.5 in In distribution
46-2628 Length 9.5 in In distribution
46-3133 Length 9.5 in In distribution
46-3156 Length 8.5 in In distribution
46-3155 Length 8.5 in In distribution
46-2648 Length 9.5 in Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Life Instruments Life Instrument Corp. 1,651
Sklar® Sklar Corporation 537
gSource Gsource, LLC. 498
Aesculap Aesculap AG 477
Surtex Surtex Instruments Ltd 462
HNM Medical HNM Stainless, LLC. 412
Curette Koros U.S.A., Inc. 341
Boss Instruments Boss Instruments, Ltd. 311
Gen2 Surgix Medical LLC 301
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 295
Symmetry Surgical Aspen Surgical Products, Inc. 248
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 192

Showing 12 of 245. All products under Curette, Surgical, General Use

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