What is FDA product code HRX?

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Allograft · Arthroscope → Orthopedic

Name: Allograft
Brand: Allograft

21manufacturers in China registered for this device type

1catalogue number

9510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Shanghai (7), Jiangsu (6), Guangdong (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HRX
Manufacturer	City	Province	Registered as	Device types
Modern Medical Equipment Manufacturing Ltd.	Heng Li, Dongguan	Guangdong	Contract manufacturer	26
Dongguan BAO Kang Dian ZI KE JI Limited	Dongguan	Guangdong	Contract manufacturer	24
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Peter’s Technology (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	9
Jiangsu Shenli Medical Production Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	6
PAN-International Precision Electronic Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	4
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Hangzhou Fushan Medical Appliance Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	44
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38
Goals Sterilization Co., Ltd.	Jiaxing	Zhejiang	Contract manufacturer	26

Showing 12 of 21. All 21 manufacturers in China registered for Arthroscope

Record

Regulatory record for Allograft
Listed by	Hydrocision, Inc., United States
FDA product code	HRX
Device type	Arthroscope
Device class	Class 2
Regulation	21 CFR 888.1100
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K002764
Record published	2017-08-21
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Allograft
Catalogue number	Size	Status
53150		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Surgical Direct	Surgical Direct, Inc.	299
Arthroscope	Karl Storz GmbH & Co. KG	278
Conmed/Linvatec	Provision	265
Arthroscope	Smith & Nephew, Inc.	255
Medline	Medline Industries, Inc.	205
Arthroscope	Sterilmed, Inc.	184
Sustainable Technologies	Provision	150
Medline Renewal	Medline Industries, Inc.	123
Stryker	Provision	113
Arthrex®	Arthrex, Inc.	109
Arthrex	Provision	109
Eberle	Eberle GmbH & Co. KG	92

Showing 12 of 567. All products under Arthroscope

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K241990	2025-07-30
K200729	2020-04-16
K190804	2019-06-05
K041233	2004-07-28
K032529	2003-09-16
K020688	2002-04-03
K002764	2000-11-24
K993009	1999-10-25
K982266	1998-09-25

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2006-09-07	Not classified	Process change control	Distal tip may become detached from the device	40 total	2006-12-06
2006-09-07	Not classified	Process change control	Distal tip may become detached from the device	40 total	2006-12-06

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.

Allograft