Fastener, Fixation, Nondegradable, Soft Tissue
11x30mm Titanium Interference Screw with 1.5mm cannulation
7manufacturers in China registered for this device type
74catalogue numbers in this listing
23510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Renolit Hansen Packaging Tech. (BJ) Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Parcus Medical, LLC, United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K113730 |
| Record published | 2018-11-19 |
| Record revised | 2019-03-21 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 2.8 to 12 mm; length 20 to 35 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10994 | Outer Diameter 3.5 mm | In distribution | |
| 11339 | Outer Diameter 3.5 mm | In distribution | |
| 11175 | Outer Diameter 4.5 mm | In distribution | |
| 10039 | Length 30 mm | In distribution | |
| 10002B | Length 25 mm | In distribution | |
| 10023 | Length 30 mm | In distribution | |
| 10005B | Length 20 mm | In distribution | |
| 10031 | Length 30 mm | In distribution | |
| 10168 | Length 35 mm | In distribution | |
| 10028 | Length 35 mm | In distribution | |
| 10312 | Outer Diameter 2.8 mm | 6 | In distribution |
| 10312 | Outer Diameter 2.8 mm | In distribution | |
| 10027 | Length 30 mm | In distribution | |
| 11321H | Outer Diameter 2.8 mm | In distribution | |
| 10025 | Length 20 mm | In distribution | |
| 10314 | Outer Diameter 4.5 mm | In distribution | |
| 10009 | Length 20 mm | In distribution | |
| 10011B | Length 30 mm | In distribution | |
| 10024 | Length 35 mm | In distribution | |
| 10035 | Length 30 mm | In distribution | |
| 10314 | Outer Diameter 4.5 mm | 6 | In distribution |
| 10007 | Length 30 mm | In distribution | |
| 10012B | Length 35 mm | In distribution | |
| 10003B | Length 30 mm | In distribution | |
| 10164 | Length 30 mm | In distribution | |
| 10163 | Length 25 mm | In distribution | |
| 10032 | Length 35 mm | In distribution | |
| 10001B | Length 20 mm | In distribution | |
| 10165 | Length 35 mm | In distribution | |
| 10020 | Length 35 mm | In distribution | |
| 10315 | Outer Diameter 5.5 mm | 6 | In distribution |
| 10323T | Outer Diameter 3.5 mm | In distribution | |
| 11321 | Outer Diameter 2.8 mm | In distribution | |
| 10005 | Length 20 mm | In distribution | |
| 10312H | Outer Diameter 2.8 mm | 6 | In distribution |
| 10166 | Length 25 mm | In distribution | |
| 10018 | Length 25 mm | In distribution | |
| 10019 | Length 30 mm | In distribution | |
| 10167 | Length 30 mm | In distribution | |
| 10009B | Length 20 mm | In distribution | |
| 10003 | Length 30 mm | In distribution | |
| 10036 | Length 35 mm | In distribution | |
| 10313 | Outer Diameter 3.5 mm | 6 | In distribution |
| 10012 | Length 35 mm | In distribution | |
| 10006B | Length 25 mm | In distribution | |
| 10004B | Length 35 mm | In distribution | |
| 10030 | Length 25 mm | In distribution | |
| 10021 | Length 20 mm | In distribution | |
| 10323T | Outer Diameter 3.5 mm | 6 | In distribution |
| 10034 | Length 25 mm | In distribution | |
| 10022 | Length 25 mm | In distribution | |
| 10016 | Length 35 mm | In distribution | |
| 10313 | Outer Diameter 3.5 mm | In distribution | |
| 10008B | Length 35 mm | In distribution | |
| 10994 | Outer Diameter 3.5 mm | 6 | In distribution |
| 10015 | Length 30 mm | In distribution | |
| 10407T | Outer Diameter 3.5 mm | 6 | In distribution |
| 10038 | Length 25 mm | In distribution | |
| 10040 | Length 35 mm | In distribution | |
| 10006 | Length 25 mm | In distribution | |
| 10007B | Length 30 mm | In distribution | |
| 11176 | Outer Diameter 4.5 mm | In distribution | |
| 10004 | Outer Diameter 7 mm | In distribution | |
| 10010 | Length 25 mm | In distribution | |
| 10315 | Outer Diameter 5.5 mm | In distribution | |
| 10029 | Length 20 mm | In distribution | |
| 10407 | Outer Diameter 3.5 mm | In distribution | |
| 10008 | Length 35 mm | In distribution | |
| 10026 | Length 25 mm | In distribution | |
| 10312H | Outer Diameter 2.8 mm | In distribution | |
| 10010B | Length 25 mm | In distribution | |
| 10014 | Length 25 mm | In distribution | |
| 10011 | Length 30 mm | In distribution | |
| 10002 | Length 25 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors | GM DOS Reis Industria E Comercio Ltda | 78 |
| Juggerknot® | Biomet Orthopedics | 77 |
| endophix | Suzhou Endophix Co., Ltd. | 71 |
| Titan | Medline Industries, Inc. | 68 |
| TopLock | Fusion Orthopedics, LLC | 67 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
| Twinfix | Smith & Nephew, Inc. | 45 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221502 | 2022-07-26 |
| K221135 | 2022-05-19 |
| K212739 | 2021-10-06 |
| K202662 | 2021-02-22 |
| K202259 | 2020-10-28 |
| K201083 | 2020-07-23 |
| K193295 | 2020-01-23 |
| K192750 | 2020-01-16 |
| K192964 | 2019-11-22 |
| K191783 | 2019-10-09 |
| K190375 | 2019-04-24 |
| K183331 | 2019-02-07 |
| K170877 | 2017-06-02 |
| K170327 | 2017-03-30 |
| K162198 | 2016-11-18 |
| K152711 | 2015-11-20 |
| K133757 | 2014-02-04 |
| K122805 | 2013-02-05 |
| K120942 | 2012-04-20 |
| K113730 | 2012-01-17 |
| K091094 | 2009-09-30 |
| K090923 | 2009-06-30 |
| K090075 | 2009-03-06 |
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.