Perfecta

SLT Taper Cocr Hemi Head 47MM OD Medium Neck

Registry build 21.09.26
10manufacturers in China registered for this device type
35catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KWL
Manufacturer City Province Registered as Device types
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Stryker (Suzhou) Medical Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Xian Airfoil Technology Co., Ltd. Xian Shaanxi Contract manufacturer 8
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Shanghai JPY ION-Tech Co., Ltd. Shanghai Shanghai Contract manufacturer 70
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34

Record

Regulatory record for Perfecta
Listed by Microport Orthopedics Inc., United States
FDA product code KWL
Device type Prosthesis, Hip, Hemi-, Femoral, Metal
Device class Class 2
Regulation 21 CFR 888.3360
Establishment Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2015-10-20
Record revised 2020-04-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Sizes Lumen/inner diameter 43 to 60 mm

Catalogue Numbers

Catalogue numbers for Perfecta
Catalogue number Size Status
36090047 Lumen/Inner Diameter 47 mm In distribution
36090049 Lumen/Inner Diameter 49 mm In distribution
36090458 Lumen/Inner Diameter 58 mm In distribution
36090447 Lumen/Inner Diameter 47 mm In distribution
36090053 Lumen/Inner Diameter 53 mm In distribution
36090045 Lumen/Inner Diameter 45 mm In distribution
36090459 Lumen/Inner Diameter 59 mm In distribution
36090054 Lumen/Inner Diameter 54 mm In distribution
36090058 Lumen/Inner Diameter 58 mm In distribution
36090454 Lumen/Inner Diameter 54 mm In distribution
36090448 Lumen/Inner Diameter 48 mm In distribution
36090456 Lumen/Inner Diameter 56 mm In distribution
36090059 Lumen/Inner Diameter 59 mm In distribution
36090044 Lumen/Inner Diameter 44 mm In distribution
36090046 Lumen/Inner Diameter 46 mm In distribution
36090450 Lumen/Inner Diameter 50 mm In distribution
36090453 Lumen/Inner Diameter 53 mm In distribution
36090060 Lumen/Inner Diameter 60 mm In distribution
36090050 Lumen/Inner Diameter 50 mm In distribution
36090446 Lumen/Inner Diameter 46 mm In distribution
36090452 Lumen/Inner Diameter 52 mm In distribution
36090445 Lumen/Inner Diameter 45 mm In distribution
36090052 Lumen/Inner Diameter 52 mm In distribution
36090449 Lumen/Inner Diameter 49 mm In distribution
36090451 Lumen/Inner Diameter 51 mm In distribution
36090460 Lumen/Inner Diameter 60 mm In distribution
36090057 Lumen/Inner Diameter 57 mm In distribution
36090455 Lumen/Inner Diameter 55 mm In distribution
36090051 Lumen/Inner Diameter 51 mm In distribution
36090043 Lumen/Inner Diameter 43 mm In distribution
36090055 Lumen/Inner Diameter 55 mm In distribution
36090444 Lumen/Inner Diameter 44 mm In distribution
36090443 Lumen/Inner Diameter 43 mm In distribution
36090048 Lumen/Inner Diameter 48 mm In distribution
36090056 Lumen/Inner Diameter 56 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ustar II Knee System United Orthopedic Corp. 115
Consensus Hip System Shalby Advanced Technologies, Inc. 95
Consensus® Hip System Consensus Orthopedics, Inc. 95
Instrument Howmedica Osteonics Corp 94
UHR Howmedica Osteonics Corp 75
Austin Moore Howmedica Osteonics Corp 67
B-P Total HIP System Endotec, Inc. 66
CS2 Acetabular Cup System Consensus Orthopedics, Inc. 64
DJO Surgical Encore Medical, L.P. 62
Restoration Howmedica Osteonics Corp 56
Optimom Modular Heads Corin Limited 49
Corin Unipolar Modular Head Corin Limited 36

Showing 12 of 167. All products under Prosthesis, Hip, Hemi-, Femoral, Metal

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