Prophecy

1,463 catalogue numbers from PNV06895, listed by Microport Orthopedics Inc., United States, under Knee Arthroplasty Implantation System. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26
2manufacturers in China registered for this device type
1,463catalogue numbers in this listing

Who Else Makes It

Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OOG
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

Record

Regulatory record for Prophecy
Listed by Microport Orthopedics Inc., United States
FDA product code OOG
Device type Knee Arthroplasty Implantation System
Device class Class 2
Regulation 21 CFR 888.3560
Establishment Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Record published 2018-12-03
Record revised 2018-03-29 (version 2)

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
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Prophecy
Catalogue number Size Status
PNV06895 In distribution
PNV03807 In distribution
PNV02812 In distribution
PNV03679 In distribution
PNV04523 In distribution
PNF05238 In distribution
PNV06752 In distribution
PNV04896 In distribution
PNV05868 In distribution
PNV06415 In distribution
PNV06871 In distribution
PNV05085 In distribution
PNV02924 In distribution
PNV05337 In distribution
PNF05335 In distribution
PNV06916 In distribution
PNV04678 In distribution
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PNV05659 In distribution
PNV04589 In distribution
PNV02703 In distribution
PNV05240 In distribution
PNV02882 In distribution
PNV04745 In distribution
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PNV05385 In distribution
PNF05109 In distribution
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Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
PointCloud Knee Instruments Unik Orthopedics, Inc 202
iTotal Identity CR ConforMIS, Inc. 138
My Knee Femoral Cutting Blocks Medacta International SA 60
iTotal® CR iPoly™ Insert Kit ConforMIS, Inc. 59
My Knee Tibial Cutting Blocks Medacta International SA 48
My Knee Femoral Cutting Blocks MIS Medacta International SA 42
My Knee Tibial Cutting Blocks MIS Medacta International SA 36
iTotal® Identity Cruciate Retaining Knee Replacement System ConforMIS, Inc. 27
iTotal® CR iPoly® XE Insert Kit ConforMIS, Inc. 16
Zimmer Patient Specific Instruments Materialise NV 12
iTotal Identity CR Knee Replacement System ConforMIS, Inc. 12
iTotal® PS iPoly® XE Insert Kit ConforMIS, Inc. 11

Showing 12 of 95. All products under Knee Arthroplasty Implantation System

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