Who else makes this device?

Name: Seitz Solution Radial Head Implant System 18 x 11mm Radial Head
Brand: Seitz Solution Radial Head Implant System 18 x 11mm Radial Head

Seitz Solution Radial Head Implant System 18 X 11mm Radial Head · Prosthesis, Elbow, Hemi-, Radial, Polymer → Orthopedic

3manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (2), Jiangsu (1).

Chinese manufacturers registered for FDA product code KWI
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70
Johnson & Johnson Medical (Depuy – Suzhou) Ltd.	Suzhou	Jiangsu	Manufacturer	34

Record

Regulatory record for Seitz Solution Radial Head Implant System 18 x 11mm Radial Head
Listed by	Kapp Surgical Instrument, Inc., United States
FDA product code	KWI
Device type	Prosthesis, Elbow, Hemi-, Radial, Polymer
Device class	Class 2
Regulation	21 CFR 888.3170
510(k)	K030237
Record published	2023-06-09

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Seitz Solution Radial Head Implant System 18 x 11mm Radial Head
Catalogue number	Size	Status
KCHI-1811		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Acumed	Acumed LLC	175
Align	Skeletal Dynamics L.L.C.	97
Prosthesis, Elbow, Hemi-, Radial, Polymer	Synthes (U.S.A.) LP	78
Evolve	Wright Medical Technology, Inc.	75
Rhead	Stryker GmbH	53
L2L™	Zimmer, Inc.	48
Prosthesis, Elbow, Hemi-, Radial, Polymer	Synthes Gmbh	43
Explor	Biomet Orthopedics	32
Avenger	IN2BONES USA, LLC	32
BioPoly® Radial Head Implant	Biopoly, LLC	30
Seitz Solution Radial Head	Kapp Surgical Instrument, Inc.	27
Integra®	Ascension Orthopedics, Inc.	23

Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K030237	2003-08-29

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.

Seitz Solution Radial Head Implant System 18 X 11mm Radial Head