Who else makes this device?

Name: TC-100
Brand: TC-100

TC-100 · Cerclage, Fixation → Orthopedic

5manufacturers in China registered for this device type

2catalogue numbers in this listing

3510(k) clearances naming this product code

2recalls on this code

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 TC-100
Listed by	Smith & Nephew, Inc., United States
FDA product code	JDQ
Device type	Cerclage, Fixation
Device class	Class 2
Regulation	21 CFR 888.3010
Establishment	Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2015-08-29
Record revised	2024-02-19 (version 5)

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
Packaging	Box of 6
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for TC-100
Catalogue number	Size	Status
71163008		In distribution
71163006		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
K233949	2024-03-13
K043252	2005-01-14
K031162	2003-05-01

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
2010-06-28	Not classified	Process control	Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.	34 units	2012-01-23
2010-06-28	Not classified	Process control	Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, compromising sterility.	1 unit	2012-01-23

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.

TC-100