Who else makes this device?

Name: Figure 8 Sternotomy Closure Device
Brand: Figure 8 Sternotomy Closure Device

Figure 8 Sternotomy Closure Device · Cerclage, Fixation → Orthopedic

5manufacturers in China registered for this device type

6catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Concentrated in Shanghai (2), Zhejiang (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JDQ
Manufacturer	City	Province	Registered as	Device types
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
Suzhou Elite Precision Machinery Co., Ltd.	Kunshan	Jiangsu	Contract manufacturer	35
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38

Record

Regulatory record for Figure 8 Sternotomy Closure Device
Listed by	Figure 8 Surgical, Incorporated, United States
FDA product code	JDQ
Device type	Cerclage, Fixation
Device class	Class 2
Regulation	21 CFR 888.3010
Record published	2017-12-20
Record revised	2018-03-29 (version 2)

Specifications

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

Catalogue Numbers

Catalogue numbers for Figure 8 Sternotomy Closure Device
Catalogue number	Size	Status
FP-20188		In distribution
20155		In distribution
FP-20186		In distribution
FP-20189		In distribution
FP-20190		In distribution
FP-20187		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cerclage, Fixation	Synthes Gmbh	102
Optilink	Synthes Gmbh	61
Songer® Spinal Cable System	Pioneer Surgical Technology, Inc.	60
DePuy Songer Spinal Cable System	Pioneer Surgical Technology, Inc.	36
Tritium® Sternal Cable Plate System	Pioneer Surgical Technology, Inc.	34
Dall-Miles	Howmedica Osteonics Corp	22
Sternal Cable System	Pioneer Surgical Technology, Inc.	20
Sternal Cable System	A & E Medical Corporation	19
Compression Screw System	Biomet Orthopedics	18
Accord	Smith & Nephew, Inc.	15
Cable-Ready®	Zimmer, Inc.	14
Arthrex®	Arthrex, Inc.	10

Showing 12 of 56. All products under Cerclage, Fixation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K110541	2011-07-06

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.

Figure 8 Sternotomy Closure Device