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).

Balloon Kyphoplasty Essentials · Arthroscope → Orthopedic

Name: Balloon Kyphoplasty Essentials
Brand: Balloon Kyphoplasty Essentials

21manufacturers in China registered for this device type

5catalogue numbers in this listing

3510(k) clearances naming this product 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 Balloon Kyphoplasty Essentials
Listed by	Medtronic Sofamor Danek, Inc., United States
FDA product code	HRX
Device type	Arthroscope
Device class	Class 2
Regulation	21 CFR 888.1100
510(k)	K041454
Record published	2019-01-26

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number
Storage	Special storage condition: Store in a cool, dry place

Catalogue Numbers

Catalogue numbers for Balloon Kyphoplasty Essentials
Catalogue number	Size	Status
NH102PB		In distribution
NH103PB		In distribution
NH152PB		In distribution
NH203PB		In distribution
NH153PB		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
K043568	2005-01-25
K040483	2004-07-23
K002931	2000-11-24

Recalls Naming This Product

5 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Balloon Kyphoplasty Essentials
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Medtronic Sofamor Danek USA, Inc.	510(k) number	2020-04-24	Class II	Under Investigation by firm	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patien	41 units	2021-03-31
Medtronic Sofamor Danek USA, Inc.	510(k) number	2020-04-24	Class II	Under Investigation by firm	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patien	36 units	2021-03-31
Medtronic Sofamor Danek USA, Inc.	510(k) number	2020-04-24	Class II	Under Investigation by firm	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patien	6 units	2021-03-31
Covidien	510(k) number	2011-03-23	Not classified	Employee error	Device was shipped past the labeled expiration date.	44	2011-09-09
Covidien	510(k) number	2009-02-04	Not classified	Process change control	Product not sterile: 10 units were released for distribution without undergoing sterilization process.	10 units affected.	2009-07-14

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.

Balloon Kyphoplasty Essentials