Conformis Hip System

HIP-Cordera Trial Necks-SET OF 4 (29.0MM IN 127, 132DEG; 36.5MM IN 127, 132DEG)

Registry build 21.09.26
53manufacturers in China registered for this device type
80catalogue 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 Conformis Hip System
Listed by ConforMIS, Inc., United States
FDA product code LXH
Device type Orthopedic Manual Surgical Instrument
Device class Class 1
Regulation 21 CFR 888.4540
Establishment Remanufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2020-06-02
Record revised 2023-10-04 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Sizes Outer diameter 3.5 to 65 mm; outer diameter 0.125 in

Catalogue Numbers

Catalogue numbers for Conformis Hip System
Catalogue number Size Status
1080-620 3.5MM X 50MM In distribution
1080-602 Outer Diameter 56 mm In distribution
HAA050D00N01 In distribution
1080-568 In distribution
1080-613 Outer Diameter 0.125 in In distribution
1080-633 32MM, XL In distribution
1080-611 Outer Diameter 65 mm In distribution
1080-639 40MM, MD In distribution
1080-567 In distribution
1080-606 Outer Diameter 60 mm In distribution
1080-571 In distribution
1080-637 36MM, XL In distribution
1080-609 Outer Diameter 63 mm In distribution
1080-641 40MM, XL In distribution
1080-603 Outer Diameter 57 mm In distribution
1080-596 Outer Diameter 50 mm In distribution
1080-612 3.18MM X 80MM In distribution
1080-565 Outer Diameter 28 mm In distribution
1080-578 Outer Diameter 15 mm In distribution
1080-583 Outer Diameter 40 mm In distribution
1080-558 In distribution
1080-569 In distribution
1080-625 Outer Diameter 44 mm In distribution
1080-607 Outer Diameter 61 mm In distribution
1080-601 Outer Diameter 55 mm In distribution
1080-561 Outer Diameter 3.5 mm In distribution
1080-632 32MM, L In distribution
1080-573 Outer Diameter 10 mm In distribution
HAR000S24401 Outer Diameter 44 mm In distribution
1080-591 Outer Diameter 45 mm In distribution
1080-631 32MM, MD In distribution
1080-581 Outer Diameter 32 mm In distribution
1080-626 In distribution
1080-608 Outer Diameter 62 mm In distribution
1080-575 Outer Diameter 12 mm In distribution
1080-594 Outer Diameter 48 mm In distribution
1080-577 Outer Diameter 14 mm In distribution
1080-638 40MM, SH In distribution
1080-572 Outer Diameter 9 mm In distribution
1080-610 Outer Diameter 64 mm In distribution
1080-618 In distribution
1080-629 3.5MM, 5.5MM In distribution
1080-560 Outer Diameter 3.5 mm In distribution
1080-615 In distribution
1080-617 Outer Diameter 3.5 mm In distribution
1080-557 In distribution
1080-597 Outer Diameter 51 mm In distribution
1080-579 Outer Diameter 16 mm In distribution
1080-642 In distribution
1080-621 In distribution
1080-582 Outer Diameter 36 mm In distribution
1080-605 Outer Diameter 59 mm In distribution
1080-600 Outer Diameter 54 mm In distribution
1080-562 In distribution
1080-599 Outer Diameter 53 mm In distribution
1080-640 40MM, L In distribution
1080-630 In distribution
1080-593 Outer Diameter 47 mm In distribution
1080-643 In distribution
1080-623 In distribution
1080-580 Outer Diameter 28 mm In distribution
1080-570 In distribution
1080-636 36MM, L In distribution
1080-604 Outer Diameter 58 mm In distribution
1080-635 36MM, MD In distribution
1080-564 In distribution
1080-566 Outer Diameter 6.5 mm In distribution
1080-598 Outer Diameter 52 mm In distribution
1080-634 36MM, SH In distribution
1080-614 Outer Diameter 38 mm In distribution
1080-576 Outer Diameter 13 mm In distribution
1080-592 Outer Diameter 46 mm In distribution
1080-622 In distribution
HAR000S14401 Outer Diameter 44 mm In distribution
1080-628 In distribution
1080-616 8MM X 20MM In distribution
1080-627 In distribution
1080-619 3.5MM X 35MM In distribution
1080-574 Outer Diameter 11 mm In distribution
1080-595 Outer Diameter 49 mm 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