Who else makes this device?

Name: Retention Device, Suture
Brand: Retention Device, Suture

Retention Device, Suture → General & Plastic Surgery

3manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

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

Chinese manufacturers registered for FDA product code KGS
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Zhejiang Mediunion Healthcare Group Co., Ltd.	Ningbo	Zhejiang	Contract manufacturer	105
MicroPort Orthopedics Global Supply Center Limited	Shanghai	Shanghai	Contract manufacturer	82

Record

Regulatory record for Retention Device, Suture
Listed by	Synthes Gmbh, Switzerland
FDA product code	KGS
Device type	Retention Device, Suture
Device class	Class 1
Regulation	21 CFR 878.4930
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K994364
Record published	2015-09-14
Record revised	2025-11-20 (version 10)

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

Catalogue Numbers

Catalogue numbers for Retention Device, Suture
Catalogue number	Size	Status
482.823		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Bioseal Inc.	Bioseal	20
Xtendobutton	Smith & Nephew, Inc.	7
Dynamic Tissue Systems™	Southmedic, Inc.	4
Retention Device, Suture	Smith & Nephew, Inc.	2
Vive	Vive Health LLC	2
Perchik	AngioDynamics, Inc.	2
FlowStasis	Inari Medical, Inc.	2
Stent Buttons	Boston Medical Products, Inc.	2
Medline Industries, Inc.	Medline Industries, Inc.	2
Medline	Medline Industries, Inc.	2
Slip-Not®	Merit Medical Systems, Inc.	2
Poly Suture Button	Biomet Sports Medicine	2

Showing 12 of 29. All products under Retention Device, Suture

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Retention Device, Suture
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Synthes (USA) Products LLC	510(k) number	2016-05-31	Class II	Under Investigation by firm	DePuy Synthes is voluntarily initiating a recall due to affected devices being distributed and or labeled with MR Safety information that does not meet the current ASTM standard.	6,255 units	2017-04-25

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.

Retention Device, Suture