FDA Device Registration & Listing · Hoelstein Basel-Landschaft, CH · Registration 3010287737
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2013-01-25 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2013-12-04 |
| HXC | Wrench | Orthopedic | Class 1 | 888.4540 | 2013-01-25 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-01-25 |
| HWA | Impactor | Orthopedic | Class 1 | 888.4540 | 2013-01-25 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | Class 1 | 878.4820 | 2013-12-04 |
| HWB | Extractor | Orthopedic | Class 1 | 888.4540 | 2013-01-25 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-25 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2026-06-05 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2026-06-05 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2021-04-28 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2021-04-28 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Orthopedic | Class 2 | 888.3690 | 2021-04-28 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Orthopedic | Class 2 | 888.3660 | 2021-04-28 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3650 | 2021-04-28 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | Orthopedic | Class 2 | 888.3660 | 2025-08-19 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Orthopedic | Class 2 | 888.3660 | 2021-04-28 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3650 | 2021-04-28 |
| HWN | Instrument, Compression | Orthopedic | Class 1 | 888.4540 | 2025-08-22 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-25 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2013-01-25 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2013-01-25 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2024-02-15 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | Class 2 | 888.3360 | 2024-02-15 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2024-02-15 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2024-02-15 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2024-02-15 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Orthopedic | Class 2 | 888.3353 | 2024-02-15 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2025-08-22 |
| DZJ | Driver, Wire, And Bone Drill, Manual | Dental | Class 2 | 872.4120 | 2025-04-11 |
| DZI | Drill, Bone, Powered | Dental | Class 2 | 872.4120 | 2025-04-11 |
| HWR | Driver, Prosthesis | Orthopedic | Class 1 | 888.4540 | 2023-04-21 |
| GFG | Bit, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2013-01-25 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | Class 2 | 888.3560 | 2021-11-03 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3560 | 2021-11-03 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | Class 2 | 888.3565 | 2021-11-03 |
| GFC | Driver, Surgical, Pin | General, Plastic Surgery | Class 1 | 878.4820 | 2013-12-04 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2016-03-03 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2019-11-08 |
| HWX | Tap, Bone | Orthopedic | Class 1 | 888.4540 | 2013-01-25 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2019-11-08 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2013-12-04 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2013-12-04 |
| HWM | Osteotome | General, Plastic Surgery | Class 1 | 878.4800 | 2019-11-08 |
| HXT | Tape, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2025-08-22 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-25 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2024-03-25 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2024-03-25 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2024-03-25 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | Class 2 | 888.3360 | 2024-03-25 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Orthopedic | Class 2 | 888.3660 | 2021-04-28 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-01-25 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2013-01-25 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2013-01-25 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | Class 2 | 888.3358 | 2013-01-25 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2013-01-25 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Orthopedic | Class 2 | 888.3070 | 2013-01-25 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2025-12-10 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | Class 2 | 888.3390 | 2024-03-25 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | Class 2 | 888.3350 | 2024-03-25 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | Class 2 | 888.3353 | 2024-03-25 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Orthopedic | Class 2 | 888.3360 | 2024-03-25 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Orthopedic | Class 2 | 888.3310 | 2024-03-25 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | Orthopedic | Class 2 | 888.3360 | 2024-03-25 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2013-01-25 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | Class 2 | 888.3020 | 2013-01-25 |
| OLO | Orthopedic Stereotaxic Instrument | Neurology | Class 2 | 882.4560 | 2024-03-12 |
| LLZ | System, Image Processing, Radiological | Radiology | Class 2 | 892.2050 | 2024-03-12 |
| LYS | Bone Mill | Orthopedic | Class 1 | 888.4540 | 2013-01-25 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K852723 | The Huxley Instrument Corp. | FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 | 1985-07-15 |
| K873512 | Arthropedics, Inc. | SERRATED GRASPING FORCEPS, RIGHT | 1987-11-02 |
| K080013 | Agfa Healthcare Corporation | REGISTRATION AND FUSION | 2008-01-17 |
| K042221 | Barco NV Barcoview | CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM | 2004-12-30 |
| K092915 | Cedara Software Corp. | CEDARA WEBACCESS, MODEL: 2.4 | 2010-06-23 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Z-0010-2007 | Smith & Nephew Inc | 1 | Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486 |
| Z-0011-06 | Stryker Howmedica Osteonics Corp. | 1 | Allocraft TLIF Bone Inserter. |
| Z-0011-2007 | Smith & Nephew Inc | 1 | Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105 |
| Z-0013-2011 | Depuy Orthopaedics, Inc. | 1 | Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143
Catalog Number: 2570-00-000
The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3014725904 | Medtronic Medical Costa Rica S.R.L. | Coyol Alajuela, CR |
| 3040335671 | Stryker Ireland Ltd. Instruments Division, Innovation Centre | Carrigtwohill Cork (County), IE |
| 3010363503 | FRUEH VERPACKUNGSTECHNIK AG | Fehraltorf Zurich, CH |
| 3010673850 | MK medical GmbH | Emmingen-Liptingen Baden-Wurttemberg, DE |
| 3008812560 | Synthes (USA) Products LLC | West Chester, PA, US |
3010287737 when referencing this establishment in official correspondence.