FDA Device Registration & Listing · Fairfield, NJ, US · Registration 3042508254
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2021-04-13 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2021-04-13 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| HTS | Knife, Orthopedic | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| HWD | Starter, Bone Screw | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2022-02-03 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2022-02-03 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2022-10-24 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| HTW | Bit, Drill | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2024-12-03 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2024-12-03 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2024-12-03 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2026-06-01 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2019-01-28 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2021-04-21 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 2019-01-28 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2019-01-28 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2019-01-28 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2020-10-30 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2019-01-28 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3015259876 | B-ONE ORTHO, CORP. | Cedar Knolls, NJ, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K030151 | Hayes Medical, Inc. | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM | 2003-04-10 |
| K153381 | Corin U.S.A. Limited | Corin Metafix Hip Stem | 2016-01-21 |
| K140975 | Lima Corporate S.P.A. | MASTERSL FEMORAL STEM | 2014-06-10 |
| K932222 | Dow Corning Wright | SLT FEMORAL HEAD | 1994-05-27 |
| K910547 | Turnkey Intergration USA, Inc. | FELDMUEHLE CERAMIC HEAD (12/14 X 28MM) | 1991-04-12 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0001-2019 | Smith & Nephew, Inc. | 2 | Journey BCS Knee CoCr Femoral Components, Catalog Numbers:
74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229 |
| Z-0002-2019 | Smith & Nephew, Inc. | 2 | JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149 |
| Z-0003-2017 | Zimmer Biomet, Inc. | 2 | Vanguard 360 Revision Knee System
Knee prostheses |
| Z-0003-2019 | Smith & Nephew, Inc. | 2 | JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326 |
| Z-0013-06 | Plus Orthopedics USA | 2 | TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3021386586 | LINCOTEK (WUXI) CO., LTD. | Wuxi Jiangsu, CN |
| 3005061536 | SYMMETRY MEDICAL MANUFACTURING INC | CLAYPOOL, IN, US |
| 3007923096 | Changzhou Biomet Medical Devices Co., Ltd. | Changzhou City Jiangsu, CN |
| 3005562917 | BGS Beta-Gamma-Service GmbH & Co KG | Bruchsal Baden-Wurttemberg, DE |
| 1450662 | Isomedix Operations, Inc. | Libertyville, IL, US |
3042508254 when referencing this establishment in official correspondence.