Who else makes this device?

Name: TorqLoc Interference
Brand: TorqLoc Interference

TorqLoc Interference · Fastener, Fixation, Biodegradable, Soft Tissue → Orthopedic

2manufacturers in China registered for this device type

27catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

All of them in Shanghai.

Chinese manufacturers registered for FDA product code MAI
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Arthrex (Shanghai) Co., Ltd.	Shanghai	Shanghai	Exporter	38

Record

Regulatory record for TorqLoc Interference
Listed by	Bioretec Ltd., Finland
FDA product code	MAI
Device type	Fastener, Fixation, Biodegradable, Soft Tissue
Device class	Class 2
Regulation	21 CFR 888.3030
Establishment	Manufacturer
510(k)	K130716
Record published	2018-04-25
Record revised	2024-01-03 (version 6)

Specifications

Specifications
MRI safety	MR Safe
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 15 to 30 °C; Storage environment temperature 59 to 86 °F
Sizes	Width 4 to 10 mm; length 10 to 33 mm
Distribution end date	2022-12-31

Catalogue Numbers

Catalogue numbers for TorqLoc Interference
Catalogue number	Size	Status
10-1009-0510	Width 5 mm	Withdrawn
10-1009-0720	Length 20 mm	Withdrawn
10-1009-0726	Length 26 mm	Withdrawn
10-1009-0515	Width 5 mm	Withdrawn
10-1009-0730	Width 7 mm	Withdrawn
10-1009-1028	Length 28 mm	Withdrawn
10-1009-0828	Length 28 mm	Withdrawn
10-1009-1033	Length 33 mm	Withdrawn
10-1009-0420	Width 4 mm	Withdrawn
10-1009-0830	Width 8 mm	Withdrawn
10-1009-0933	Width 9 mm	Withdrawn
10-1009-0820	Length 20 mm	Withdrawn
10-1009-0415	Width 4 mm	Withdrawn
10-1009-1030	Width 10 mm	Withdrawn
10-1009-0620	Length 20 mm	Withdrawn
10-1009-0924	Length 24 mm	Withdrawn
10-1009-0724	Width 7 mm	Withdrawn
10-1009-0410	Length 10 mm	Withdrawn
10-1009-0930	Length 30 mm	Withdrawn
10-1009-0928	Length 28 mm	Withdrawn
10-1009-0626	Width 6 mm	Withdrawn
10-1009-0615	Width 6 mm	Withdrawn
10-1009-0824	Width 8 mm	Withdrawn
10-1009-1024	Width 10 mm	Withdrawn
10-1009-0920	Width 9 mm	Withdrawn
10-1009-0520	Length 20 mm	Withdrawn
10-1009-0833	Width 8 mm	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Arthrex®	Arthrex, Inc.	545
Fix2Lock	Osteonic Co., Ltd.	118
Delta	Stryker Leibinger Gmbh & Co. KG	110
Reunite Screw System	Biomet Orthopedics	85
ComposiTCP	S.B.M	61
ActivaScrew™ Interference	Bioretec Ltd.	54
Ligafix	S.B.M	40
Twinfix	Smith & Nephew, Inc.	28
Biosure	Smith & Nephew, Inc.	27
FiberFIX	Nanova BIO Materials Inc	25
AlphaVent	Stryker GmbH	23
Twist AP Suture Anchors	Parcus Medical, LLC	17

Showing 12 of 176. All products under Fastener, Fixation, Biodegradable, Soft Tissue

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K130716	2013-08-28

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.

TorqLoc Interference