EZ-Trax™
Bracket Insert Silicone 80 (H) 2.0 (W) 1.550 Standard Round DIA..3125
5manufacturers in China registered for this device type
130catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | K1 Medical, LLC, United States |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| 510(k) | K192487 |
| Record published | 2021-02-23 |
| Record revised | 2024-09-12 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-09-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 121 LID.ASSY.AL.20.11 | In distribution | |
| 125 BRACKETINSERTFRAMEASSY-AL-2.4.-1.550 | In distribution | |
| 068 DIVIDER.2.4.15 | In distribution | |
| 179 INSERT.AL.24.12.2 | In distribution | |
| 067.00 DIVIDER.2.02 | In distribution | |
| 180 BRACKET-AL-H2.4-SZ20-P180 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.50 | In distribution | |
| 068 DIVIDER.2.4.04 | In distribution | |
| 096 DIVIDER.1.72.15 | In distribution | |
| 096 DIVIDER.1.72.04 | In distribution | |
| 067.00 DIVIDER.2.17 | In distribution | |
| 085 MMT.THA.BROACHBASE | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.38 | In distribution | |
| 096 DIVIDER.1.72.07 | In distribution | |
| 148 DECKPLATE.AL.21.12 | In distribution | |
| 096 DIVIDER.1.72.09 | In distribution | |
| 068 DIVIDER.2.4.18 | In distribution | |
| 096 DIVIDER.1.72.11 | In distribution | |
| 150 BRACKET-AL-2.0-1.875-1.25 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.88 | In distribution | |
| 183 BRACKET-AL-H2.0-SZ15-P183 | In distribution | |
| 068 DIVIDER.2.4.05 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.31 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-12MM | In distribution | |
| 096 DIVIDER.1.72.02 | In distribution | |
| 096 DIVIDER.1.72.20 | In distribution | |
| 187 BASE.ASSY.AL.12.12.2.4 | In distribution | |
| 096 DIVIDER.1.72.14 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.44 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.75 | In distribution | |
| 096 DIVIDER.1.72.12 | In distribution | |
| 096 DIVIDER.1.72.17 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.00 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-10MM | In distribution | |
| 067.00 DIVIDER.2.15 | In distribution | |
| 068 DIVIDER.2.4.07 | In distribution | |
| 067.00 DIVIDER.2.07 | In distribution | |
| 150 BRACKET-AL-2.0-1.875-1.13 | In distribution | |
| 053 BASE.ASSY.AL.24.12.2.4 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.31 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.25 | In distribution | |
| 068 DIVIDER.2.4.02 | In distribution | |
| 189 MMT.THA.BROACH.001 | In distribution | |
| 084 MMT.THA.REAMERS | In distribution | |
| 067.00 DIVIDER.2.20 | In distribution | |
| 068 DIVIDER.2.4.11 | In distribution | |
| 123 LID.ASSY.AL.25.12 | In distribution | |
| 120 BASE.ASSY.AL.20.11.6 | In distribution | |
| 128 BRAINSERT-S80-2.4-1.550-STDRD-2MM | In distribution | |
| 140 MMT.TKA.PINDRILLS | In distribution | |
| 122 BASE.ASSY.AL.25.12.4 | In distribution | |
| 060 INSERT.AL.24.12.2 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.88 | In distribution | |
| 067.00 DIVIDER.2.18 | In distribution | |
| 059 INSERT.AL.21.12.2 | In distribution | |
| 068 DIVIDER.2.4.13 | In distribution | |
| 149 DECKPLATE.AL.24.12 | In distribution | |
| 067.00 DIVIDER.2.06 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-1.25 | In distribution | |
| 068 DIVIDER.2.4.19 | In distribution | |
| 131.00 MMT.THA.REAMER.12.P001 | In distribution | |
| 068 DIVIDER.2.4.09 | In distribution | |
| 096 DIVIDER.1.72.18 | In distribution | |
| 096 DIVIDER.1.72.05 | In distribution | |
| 051 BASE.ASSY.AL.24.12.2 | In distribution | |
| 102 POST.1PC.172 | In distribution | |
| 068 DIVIDER.2.4.14 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.63 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-5MM | In distribution | |
| 182 BRACKET-AL-H2.0-SZ20-P182 | In distribution | |
| 067.00 DIVIDER.2.03 | In distribution | |
| 062 LID.ASSY.AL.21.12 | In distribution | |
| 068 DIVIDER.2.4.12 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.06 | In distribution | |
| 096 DIVIDER.1.72.19 | In distribution | |
| 067.00 DIVIDER.2.09 | In distribution | |
| 067.00 DIVIDER.2.08 | In distribution | |
| 068 DIVIDER.2.4.08 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-2MM | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.38 | In distribution | |
| 096 DIVIDER.1.72.13 | In distribution | |
| 117 INSERT.AL.21.12.2 | In distribution | |
| 116 BRACKET-AL-H2.0-SZ20-P116 | In distribution | |
| 067.00 DIVIDER.2.13 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-5MM | In distribution | |
| 101 POST.1PC.2.0 | In distribution | |
| 096 DIVIDER.1.72.10 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-10MM | In distribution | |
| 067.00 DIVIDER.2.11 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.13 | In distribution | |
| 067.00 DIVIDER.2.10 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-12MM | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.50 | In distribution | |
| 181 BRACKET-AL-H2.0-SZ20-P181 | In distribution | |
| 096 DIVIDER.1.72.06 | In distribution | |
| 096 DIVIDER.1.72.08 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.63 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.75 | In distribution | |
| 067.00 DIVIDER.2.05 | In distribution | |
| 143 BRACKETASSY.AL.INSERTFRAME-2.0-1.550 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-1.00 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-1.13 | In distribution | |
| 105 BRACKETASSY.BROACH.SZ5 | In distribution | |
| 068 DIVIDER.2.4.20 | In distribution | |
| 147 BRACKETINSERT-S80-2.0-1.875-STDRD-1.00 | In distribution | |
| 139 BRACKETASSY.BROACH.SZ7 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.06 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.25 | In distribution | |
| 118 INSERT.AL.21.12.2 | In distribution | |
| 068 DIVIDER.2.4.16 | In distribution | |
| 067.00 DIVIDER.2.12 | In distribution | |
| 096 DIVIDER.1.72.03 | In distribution | |
| 067.00 DIVIDER.2.19 | In distribution | |
| 096 DIVIDER.1.72.16 | In distribution | |
| 144 BRACKETINSERT-S80-2.0-1.550-STDRD-0.44 | In distribution | |
| 067.00 DIVIDER.2.04 | In distribution | |
| 188 MMT.THA.BROACH.STD | In distribution | |
| 060 INSERT.AL.24.12.2 | In distribution | |
| 202 Pin Caddy w/Lid 7.5.1.5.1.5 | In distribution | |
| 175 ID Plate | In distribution | |
| 107 BRACKETASSY.BROACH.SZ6 | In distribution | |
| 128 BRACKETINSERT-S80-2.4-1.550-STDRD-0.13 | In distribution | |
| 067.00 DIVIDER.2.16 | In distribution | |
| 146 BRACKETASSY.AL.INSERTFRAME-2.0-1.875 | In distribution | |
| 068 DIVIDER.2.4.17 | In distribution | |
| 137 INSERT.AL.24.12.2 | In distribution | |
| 067.00 DIVIDER.2.14 | In distribution | |
| BASEASSY.SS.21.12.4 | Withdrawn | |
| INSERT.SS.21.12.2 | Withdrawn | |
| BASEASSY.SS.21.12.2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213209 | 2021-12-28 |
| K211007 | 2021-07-01 |
| K202270 | 2020-12-02 |
| K192487 | 2019-12-23 |
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.