Knee Instrument

EM Short Sup Guide-Slim Double Vertical Pins

Registry build 21.09.26
53manufacturers in China registered for this device type
175catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LXH
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
B.Braun Medical (Suzhou) Co,.Ltd Suzhou Jiangsu Contract manufacturer 37
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Jinsheng Plastic Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17

Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument

Record

Regulatory record for Knee Instrument
Listed by Medacta International SA, Switzerland
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2023-05-15

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Knee Instrument
Catalogue number Size Status
02.12.10.2632 In distribution
02.12.10.2582 In distribution
02.12.10.2668 In distribution
02.12.10.2574 In distribution
02.07.10.8694 In distribution
02.12.10.2538 In distribution
02.12.10.2596 In distribution
02.12.10.2534 In distribution
02.12.10.2604 In distribution
02.12.10.2664 In distribution
02.12.10.2609 In distribution
02.12.10.2617 In distribution
02.12.10.2558 In distribution
02.12.10.2527 In distribution
02.12.10.2650 In distribution
02.12.10.2572 In distribution
02.12.10.2634 In distribution
02.12.10.2573 In distribution
02.12.10.2662 In distribution
02.12.10.2671 In distribution
02.12.10.2578 In distribution
02.12.10.2616 In distribution
02.12.10.2553 In distribution
02.12.10.2532 In distribution
02.12.10.2548 In distribution
02.12.10.2560 In distribution
02.12.10.2552 In distribution
02.12.10.2641 In distribution
02.12.10.2661 In distribution
02.12.10.2516 In distribution
02.12.10.2549 In distribution
02.12.10.2535 In distribution
02.07.10.8695 In distribution
02.12.10.2564 In distribution
02.12.10.2588 In distribution
02.12.10.2603 In distribution
02.12.10.2577 In distribution
02.12.10.2670 In distribution
02.12.10.2533 In distribution
02.12.10.2546 In distribution
02.12.10.2576 In distribution
02.12.10.2544 In distribution
02.12.10.2633 In distribution
02.12.10.2586 In distribution
02.12.10.2631 In distribution
02.12.10.2642 In distribution
02.12.10.2638 In distribution
02.12.10.2615 In distribution
02.12.10.2524 In distribution
02.12.10.2639 In distribution
02.12.10.2568 In distribution
02.12.10.2623 In distribution
02.12.10.2636 In distribution
02.12.10.2599 In distribution
02.12.10.2626 In distribution
02.12.10.2606 In distribution
02.12.10.2614 In distribution
02.12.10.2587 In distribution
02.12.10.2554 In distribution
02.12.10.2555 In distribution
02.12.10.2655 In distribution
02.12.10.2508 In distribution
02.12.10.2514 In distribution
02.12.10.2520 In distribution
02.07.10.8693 In distribution
02.12.10.2512 In distribution
02.12.10.2590 In distribution
02.12.10.2601 In distribution
02.12.10.2566 In distribution
02.12.10.2541 In distribution
02.12.10.2591 In distribution
02.12.10.2551 In distribution
02.12.10.2628 In distribution
02.12.10.2653 In distribution
02.12.10.2608 In distribution
02.12.10.2592 In distribution
02.12.10.2593 In distribution
02.12.10.2594 In distribution
02.12.10.2517 In distribution
02.12.10.2545 In distribution
02.12.10.2537 In distribution
02.12.10.2531 In distribution
02.12.10.2640 In distribution
02.12.10.2656 In distribution
02.12.10.2511 In distribution
02.12.10.2563 In distribution
02.12.10.2521 In distribution
02.12.10.2526 In distribution
02.12.10.2630 In distribution
02.12.10.2646 In distribution
02.12.10.2605 In distribution
02.12.10.2651 In distribution
02.07.10.8255 In distribution
02.12.10.2660 In distribution
02.12.10.2579 In distribution
02.12.10.2602 In distribution
02.12.10.2581 In distribution
02.12.10.2542 In distribution
02.12.10.2625 In distribution
02.12.10.2509 In distribution
02.12.10.2647 In distribution
02.12.10.2550 In distribution
02.12.10.2570 In distribution
02.12.10.2637 In distribution
02.12.10.2607 In distribution
02.12.10.2515 In distribution
02.12.10.2575 In distribution
02.07.10.8256 In distribution
02.12.10.2675 In distribution
02.12.10.2621 In distribution
02.12.10.2529 In distribution
02.12.10.2669 In distribution
02.12.10.2597 In distribution
02.12.10.2540 In distribution
02.12.10.2528 In distribution
02.12.10.2567 In distribution
02.12.10.2663 In distribution
02.12.10.2518 In distribution
02.12.10.2543 In distribution
02.12.10.0508 In distribution
02.12.10.2562 In distribution
02.12.10.2585 In distribution
02.12.10.2652 In distribution
02.12.10.2556 In distribution
02.12.10.2659 In distribution
02.12.10.2557 In distribution
02.12.10.2629 In distribution
02.12.10.2559 In distribution
02.12.10.2598 In distribution
02.12.10.2583 In distribution
02.12.10.0509 In distribution
02.12.10.2565 In distribution
02.07.10.8257 In distribution
02.12.10.2513 In distribution
02.12.10.2667 In distribution
02.12.10.2580 In distribution
02.12.10.2523 In distribution
02.12.10.2547 In distribution
02.12.10.2510 In distribution
02.12.10.2530 In distribution
02.12.10.2611 In distribution
02.12.10.2519 In distribution
02.12.10.2657 In distribution
02.12.10.2627 In distribution
02.12.10.2674 In distribution
02.12.10.2569 In distribution
02.12.10.2643 In distribution
02.12.10.2584 In distribution
02.12.10.2571 In distribution
02.12.10.2536 In distribution
03.29.10.0300 In distribution
02.12.10.2522 In distribution
02.12.10.2595 In distribution
02.12.10.2619 In distribution
02.12.10.2539 In distribution
02.12.10.2622 In distribution
02.12.10.2672 In distribution
02.12.10.2645 In distribution
02.12.10.2658 In distribution
02.12.10.2589 In distribution
02.12.10.2618 In distribution
02.12.10.2600 In distribution
02.12.10.2610 In distribution
02.12.10.2612 In distribution
02.12.10.2665 In distribution
02.12.10.2666 In distribution
02.12.10.2654 In distribution
02.12.10.2561 In distribution
02.12.10.2620 In distribution
02.12.10.2635 In distribution
02.12.10.2624 In distribution
02.12.10.2644 In distribution
02.12.10.2673 In distribution
02.12.10.2613 In distribution
02.12.10.2525 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Razek Equipamentos Razek Equipamentos Ltda 11,578
Orthopedic Manual Surgical Instrument Globus Medical, Inc. 4,784
Instrument Howmedica Osteonics Corp 4,539
Orthopedic Manual Surgical Instrument Ortho Development Corp. 4,076
Knee Instruments Medacta International SA 3,944
Kyocera Medical Technologies, Inc. Kyocera Medical Technologies, Inc. 3,420
Arthrex® Arthrex, Inc. 3,106
Spine Instruments Medacta International SA 2,892
Orthopedic Manual Surgical Instrument Medtronic Sofamor Danek, Inc. 2,766
Hip Instruments Medacta International SA 1,904
Medtronic Reusable Instruments Medtronic Sofamor Danek, Inc. 1,756
ReLine Nuvasive, Inc. 1,208

Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument

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