AlphaVent

Alphavent Suture Anchor 4.75MM Biocomposite, Suture Anchor With #2 Xbraid S Suture AND 1.8MM (NON-Sliding) Xbraid TT Suture Tape

Registry build 21.09.26
2manufacturers in China registered for this device type
23catalogue numbers in this listing

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 AlphaVent
Listed by Stryker GmbH, Switzerland
FDA product code MAI
Device type Fastener, Fixation, Biodegradable, Soft Tissue
Device class Class 2
Regulation 21 CFR 888.3030
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
510(k) K250528
Record published 2023-09-06

Specifications

Specifications
MRI safety MR Safe
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Handling environment temperature up to 32 °C; Storage environment temperature up to 32 °C

Catalogue Numbers

Catalogue numbers for AlphaVent
Catalogue number Size Status
3910847022 Diameter: 4.75 Millimeter In distribution
3910855022 Diameter: 5.5 Millimeter In distribution
3910847031 Diameter: 4.75 Millimeter In distribution
3910847222 Diameter: 4.75 Millimeter In distribution
3910855021 Diameter: 5.5 Millimeter In distribution
3910865032 Diameter: 6.5 Millimeter In distribution
3910865221 Diameter: 6.5 Millimeter In distribution
3910847221 Diameter: 4.75 Millimeter In distribution
3910847120 Diameter: 4.75 Millimeter In distribution
3910847132 Diameter: 4.75 Millimeter In distribution
3910855222 Diameter: 5.5 Millimeter In distribution
3910855032 Diameter: 5.5 Millimeter In distribution
3910847021 Diameter: 4.75 Millimeter In distribution
3910855221 Diameter: 5.5 Millimeter In distribution
3910847131 Diameter: 4.75 Millimeter In distribution
3910855020 Diameter: 5.5 Millimeter In distribution
3911-856-565 Diameter: 6.5 Millimeter In distribution
3910855031 Diameter: 5.5 Millimeter In distribution
3910855132 Diameter: 5.5 Millimeter In distribution
3910847032 Diameter: 4.75 Millimeter In distribution
3910865031 Diameter: 6.5 Millimeter In distribution
3910847020 Diameter: 4.75 Millimeter In distribution
3910865222 Diameter: 6.5 Millimeter In distribution

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
TorqLoc Interference Bioretec Ltd. 27
FiberFIX Nanova BIO Materials Inc 25
Twist AP Suture Anchors Parcus Medical, LLC 17

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

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer