FDA Device Registration & Listing · Salisbury, MD, US · Registration 3015895045
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HDF | Speculum, Vaginal, Metal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2008-12-17 |
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | Class 1 | 876.5520 | 2018-03-16 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2007-12-06 |
| HXS | Twister, Wire | Orthopedic | Class 1 | 888.4540 | 2017-10-11 |
| HCY | Curette, Uterine | Obstetrics/Gynecology | Class 1 | 884.4530 | 2013-05-10 |
| FZS | Curette, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2013-05-10 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2018-03-15 |
| HXZ | Cutter, Wire | Orthopedic | Class 1 | 888.4540 | 2018-12-11 |
| HDA | Forceps, Obstetrical | Obstetrics/Gynecology | Class 2 | 884.4400 | 2016-08-09 |
| FRG | Wrap, Sterilization | General Hospital | Class 2 | 880.6850 | 2016-08-09 |
| HNW | Dilator, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2018-11-13 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2016-06-29 |
| JYT | Pick, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-11-13 |
| HRH | Trephine, Manual, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2024-07-25 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2024-01-11 |
| JDW | Pin, Fixation, Threaded | Orthopedic | Class 2 | 888.3040 | 2017-12-20 |
| HTY | Pin, Fixation, Smooth | Orthopedic | Class 2 | 888.3040 | 2017-12-20 |
| HWC | Screw, Fixation, Bone | Orthopedic | Class 2 | 888.3040 | 2017-12-20 |
| HDQ | Dilator, Cervical, Fixed Size | Obstetrics/Gynecology | Class 1 | 884.4530 | 2013-05-10 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2008-12-17 |
| CCW | Laryngoscope, Rigid | Anesthesiology | Class 1 | 868.5540 | 2018-11-13 |
| FNY | Basin, Emesis | General Hospital | Class 1 | 880.6730 | 2024-07-03 |
| HKF | Mirror, Headband, Ophthalmic | Ophthalmic | Class 1 | 886.1500 | 2018-07-19 |
| HMX | Cannula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-03-19 |
| EKC | Excavator, Dental, Operative | Dental | Class 1 | 872.4565 | 2023-12-13 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2022-12-29 |
| GFJ | Mallet, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-03-19 |
| ECR | Setter, Band, Orthodontic | Dental | Class 1 | 872.4565 | 2024-01-03 |
| GDL | Needle, Suturing, Reusable | General, Plastic Surgery | Class 1 | 878.4800 | 2017-10-17 |
| KCG | Dilator, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2017-10-17 |
| FAX | Bougie, Urological | Gastroenterology, Urology | Class 1 | 876.5520 | 2019-11-19 |
| EJY | Pliers, Operative | Dental | Class 1 | 872.4565 | 2018-12-11 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2018-12-11 |
| HNC | Specula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-11-13 |
| KBP | Hook, Tonsil Suturing | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-03-23 |
| NBH | Accessories, Arthroscopic | Orthopedic | Class 1 | 888.1100 | 2023-12-11 |
| HNL | Probe, Lachrymal | Ophthalmic | Class 1 | 886.4350 | 2018-11-13 |
| GDN | Knife, Amputation | General, Plastic Surgery | Class 1 | 878.4800 | 2018-11-13 |
| KAS | Knife, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-11-13 |
| EKE | Curette, Operative | Dental | Class 1 | 872.4565 | 2018-11-13 |
| DRC | Trocar | Cardiovascular | Class 2 | 870.1390 | 2019-07-15 |
| HTZ | Instrument, Cutting, Orthopedic | General, Plastic Surgery | Class 1 | 878.4800 | 2013-05-10 |
| GEO | File, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-20 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2016-10-12 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2017-10-11 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | General Hospital | Class 2 | 880.2800 | 2017-06-19 |
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2018-07-20 |
| ERA | Otoscope | Ear, Nose, Throat | Class 1 | 874.4770 | 2018-07-20 |
| EMJ | Elevator, Surgical, Dental | Dental | Class 1 | 872.4565 | 2018-03-16 |
| LGG | Instrument, Cast Application/Removal, Manual | Orthopedic | Class 1 | 888.5980 | 2018-03-19 |
| FFQ | Speculum, Rectal | Gastroenterology, Urology | Class 1 | 876.4730 | 2008-12-17 |
| KIK | Hook, Bone | General, Plastic Surgery | Class 1 | 878.4800 | 2018-12-11 |
| KBN | Gag, Mouth | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-03-15 |
| EHY | Tray, Impression, Preformed | Dental | Class 1 | 872.6880 | 2018-11-13 |
| HNF | Scissors, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2007-12-06 |
| LXZ | Guard, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2022-03-16 |
| KCB | Tube, Tonsil Suction | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-01-11 |
| HHT | Spatula, Cervical, Cytological | Obstetrics/Gynecology | Class 2 | 884.4530 | 2017-06-19 |
| EIY | Instrument, Filling, Plastic, Dental | Dental | Class 1 | 872.4565 | 2018-03-19 |
| KBJ | Curette, Adenoid | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-11-13 |
| GAF | Spatula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-11-13 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-12-06 |
| GDH | Gouge, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-03-19 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2024-08-16 |
| GEC | Brush, Scrub, Operating-Room | General, Plastic Surgery | Class 1 | 878.4800 | 2016-06-29 |
| EMF | Knife, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-12-11 |
| KAE | Forceps, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-01 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2016-08-09 |
| FTN | Plastic Surgery And Accessories Kit | General, Plastic Surgery | Class 1 | 878.3925 | 2008-12-17 |
| EZO | Urethrotome | Gastroenterology, Urology | Class 2 | 876.4770 | 2021-02-03 |
| FZQ | Clip, Removable (Skin) | General, Plastic Surgery | Class 1 | 878.4320 | 2018-12-11 |
| HNQ | Hook, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-12-11 |
| JYL | Hook, Microsurgical Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-12-11 |
| HDL | Retractor, Vaginal | Obstetrics/Gynecology | Class 1 | 884.4520 | 2015-04-01 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | Class 1 | 878.4800 | 2015-05-13 |
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-12-06 |
| EMM | Chisel, Osteotome, Surgical | Dental | Class 1 | 872.4565 | 2018-03-23 |
| GDO | Applier, Surgical, Clip | General, Plastic Surgery | Class 1 | 878.4800 | 2018-11-13 |
| HKY | Tonometer, Manual | Ophthalmic | Class 2 | 886.1930 | 2017-12-20 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | Class 1 | 876.4730 | 2007-12-06 |
| KBC | Saw, Nasal | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-11-13 |
| KYX | Dispenser, Liquid Medication | General Hospital | Class 1 | 880.6430 | 2024-07-03 |
| NAB | Gauze / Sponge,Nonresorbable For External Use | General, Plastic Surgery | Class 1 | 878.4014 | 2008-12-17 |
| GAC | Rasp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2017-11-13 |
| HTC | Pliers, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2022-12-29 |
| EMG | Forceps, Tooth Extractor, Surgical | Dental | Class 1 | 872.4565 | 2018-11-13 |
| EMN | Scaler, Periodontic | Dental | Class 1 | 872.4565 | 2018-03-19 |
| HHW | Pessary, Vaginal | Obstetrics/Gynecology | Class 2 | 884.3575 | 2016-10-12 |
| HFB | Forceps, Biopsy, Gynecological | Obstetrics/Gynecology | Class 1 | 884.4530 | 2007-12-06 |
| KTF | Punch, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2024-02-02 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2019-05-14 |
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | Class 2 | 884.4530 | 2007-12-06 |
| EIX | Probe, Periodontic | Dental | Class 1 | 872.4565 | 2019-05-14 |
| JOK | Scissors, Medical, Disposable | General Hospital | Class 1 | 880.6820 | 2022-08-16 |
| LRY | Punch, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-12-06 |
| HND | Spatula, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-03-19 |
| HSO | Saw | General, Plastic Surgery | Class 1 | 878.4800 | 2024-01-11 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2018-11-13 |
| HCF | Instrument, Ligature Passing And Knot Tying | General, Plastic Surgery | Class 1 | 878.4800 | 2007-12-06 |
| HFX | Clamp, Circumcision | Obstetrics/Gynecology | Class 2 | 884.4530 | 2016-08-09 |
| EIS | Remover, Crown | Dental | Class 1 | 872.4565 | 2024-01-11 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | Ear, Nose, Throat | Class 1 | 874.3540 | 2018-03-23 |
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | Class 1 | 872.4565 | 2022-12-29 |
| LRO | General Surgery Tray | General, Plastic Surgery | Class 2 | 878.4370 | 2008-02-04 |
| GEG | Elevator, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2018-03-16 |
| JYO | Knife, Ear | Ear, Nose, Throat | Class 1 | 874.4420 | 2007-12-05 |
| DXQ | Blood Pressure Cuff | Cardiovascular | Class 2 | 870.1120 | 2017-02-10 |
| FMH | Container, Specimen, Sterile | Pathology | Class 1 | 864.3250 | 2024-07-03 |
| HNZ | Curette, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-03-16 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2022-12-29 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | Gastroenterology, Urology | Class 1 | 876.1500 | 2016-06-29 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2013-05-10 |
| EMI | File, Bone, Surgical | Dental | Class 1 | 872.4565 | 2018-03-15 |
| FYA | Gown, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2009-11-10 |
| GDR | Saw, Manual And Accessories | General, Plastic Surgery | Class 1 | 878.4800 | 2021-03-22 |
| HIB | Speculum, Vaginal, Nonmetal | Obstetrics/Gynecology | Class 2 | 884.4530 | 2016-08-09 |
| HXB | Probe | Orthopedic | Class 1 | 888.4540 | 2017-10-11 |
| EAX | Mirror, Mouth | Dental | Class 1 | 872.4565 | 2018-07-20 |
| EGN | Scissors, Surgical Tissue, Dental | Dental | Class 1 | 872.4565 | 2018-03-19 |
| KCP | Syringe, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2024-01-11 |
| KCH | Hook, Tracheal | Ear, Nose, Throat | Class 1 | 874.4420 | 2015-04-01 |
| EME | Punch, Biopsy, Surgical | Dental | Class 1 | 872.4565 | 2013-05-10 |
| FSP | Loupe, Diagnostic/Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2020-09-09 |
| FZT | Cutter, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2007-12-06 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2023-12-13 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-12-06 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2017-02-10 |
| FHL | Scoop | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-12-11 |
| FZZ | Marker, Skin | General, Plastic Surgery | Class 1 | 878.4660 | 2017-02-23 |
| GDF | Guide, Needle, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2013-05-10 |
| JOL | Catheter And Tip, Suction | General Hospital | Class 2 | 880.6740 | 2022-02-03 |
| FZP | Clip, Implantable | General, Plastic Surgery | Class 2 | 878.4300 | 2017-02-10 |
| MCH | Clip, Hemostatic | General, Plastic Surgery | Class 2 | 878.4300 | 2017-02-10 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | General Hospital | Class 2 | 880.6850 | 2016-08-09 |
| FHN | Ligator, Hemorrhoidal | Gastroenterology, Urology | Class 2 | 876.4400 | 2019-07-15 |
| KAD | Elevator, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-03-19 |
| KTZ | Caliper | Orthopedic | Class 1 | 888.4150 | 2024-01-11 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-03-23 |
| HWJ | Awl | Orthopedic | Class 1 | 888.4540 | 2018-03-23 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | General, Plastic Surgery | Class 1 | 878.4820 | 2018-03-15 |
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | Class 2 | 868.5730 | 2017-09-05 |
| HDX | Dilator, Vaginal | Obstetrics/Gynecology | Class 2 | 884.3900 | 2017-02-10 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2018-03-16 |
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2018-11-13 |
| EPE | Brush, Cleaning, Tracheal Tube | Anesthesiology | Class 1 | 868.5795 | 2016-06-29 |
| EML | Chisel, Bone, Surgical | Dental | Class 1 | 872.4565 | 2019-05-14 |
| HRR | Scissors, Orthopedic, Surgical | Orthopedic | Class 1 | 888.4540 | 2018-03-19 |
| GBZ | Catheter, Cholangiography | General, Plastic Surgery | Class 1 | 878.4200 | 2017-02-10 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | Class 2 | 878.4400 | 2017-02-10 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| LQR | Dislodger, Stone, Biliary | Gastroenterology, Urology | Class 2 | 876.5010 | 2017-02-10 |
| KOA | Surgical Instruments, G-U, Manual (And Accessories) | Gastroenterology, Urology | Class 1 | 876.4730 | 2017-02-10 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| FED | Endoscopic Access Overtube, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| KQT | Evacuator, Gastro-Urology | Gastroenterology, Urology | Class 2 | 876.4370 | 2017-02-10 |
| FGC | Urethroscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| FCL | Forceps, Biopsy, Non-Electric | Gastroenterology, Urology | Class 1 | 876.1075 | 2017-02-10 |
| FDE | Laparoscopy Kit | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| FJL | Resectoscope | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | Class 1 | 876.5090 | 2017-02-10 |
| EZO | Urethrotome | Gastroenterology, Urology | Class 2 | 876.4770 | 2017-02-10 |
| KOD | Catheter, Urological | Gastroenterology, Urology | Class 2 | 876.5130 | 2017-02-10 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| KOE | Dilator, Urethral | Gastroenterology, Urology | Class 2 | 876.5520 | 2017-02-10 |
| GCT | Light Source, Endoscope, Xenon Arc | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| FHA | Clamp, Penile | Gastroenterology, Urology | Class 1 | 876.5160 | 2017-02-10 |
| FAS | Electrode, Electrosurgical, Active, Urological | Gastroenterology, Urology | Class 2 | 876.4300 | 2017-02-10 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | Class 2 | 876.4300 | 2017-02-10 |
| FDC | Resectoscope, Working Element | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-10 |
| FZX | Guide, Surgical, Instrument | General, Plastic Surgery | Class 1 | 878.4800 | 2019-05-14 |
| FJY | Plier, Crimp | Gastroenterology, Urology | Class 1 | 876.5540 | 2018-12-11 |
| FGM | Probe And Director, Gastro-Urology | Gastroenterology, Urology | Class 1 | 876.4730 | 2018-03-23 |
| LYV | Label Or Tag, Sterile | General, Plastic Surgery | Class 1 | 878.4800 | 2022-03-16 |
| GDJ | Clamp, Surgical, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2007-12-06 |
| GCC | Dilator, Catheter | General, Plastic Surgery | Class 1 | 878.4200 | 2018-03-23 |
| HXG | Tamp | Orthopedic | Class 1 | 888.4540 | 2018-11-13 |
| GCJ | Laparoscope, General & Plastic Surgery | Gastroenterology, Urology | Class 2 | 876.1500 | 2017-02-28 |
| KBM | Dissector, Tonsil | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-07-19 |
| GES | Blade, Scalpel | General, Plastic Surgery | Class 1 | 878.4800 | 2018-11-13 |
| EMR | File, Periodontic | Dental | Class 1 | 872.4565 | 2019-05-14 |
| FQM | Bandage, Elastic | General Hospital | Class 1 | 880.5075 | 2008-12-17 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | Obstetrics/Gynecology | Class 1 | 884.1550 | 2008-02-05 |
| KTE | Trocar, Ent | Ear, Nose, Throat | Class 1 | 874.4420 | 2018-03-19 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 2431166 | Sklar Corporation | West Chester, PA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K223112 | Smith & Nephew, Inc. | MAVERICK Mini External Fixation System | 2022-12-08 |
| K895079 | Buckman Co., Inc. | ACE BEADED K-WIRES ACE OLIVE WIRES | 1989-09-13 |
| K922193 | Osteo AG | OSTEO KIRSCHNER WIRE | 1992-07-23 |
| K850026 | Kirkstil Corp., Inc. | ORTHOPEDIC IMPLANT NAILS & PINS | 1985-05-20 |
| K963367 | Rms Div. | RMS K-WIRE | 1996-10-30 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0034-2012 | X Spine Systems Inc | 1 | Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144
The Axle Torque Driver Handle is used to lock the set screw into the locking plate. |
| Z-0013-05 | Biomet, Inc. | 2 | Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205. |
| Z-0014-2014 | Synthes USA HQ, Inc. | 2 | Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. |
| Z-0026-2013 | Orthohelix Surgical Designs Inc | 2 | OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS
The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. |
| Z-0026-2016 | Ortho Solutions Inc 330 Franklin Tnpk | 2 | Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile
Orthopaedic Bone Screw |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3014334038 | Integra LifeSciences Production Corporation | Mansfield, MA, US |
| 3010399422 | INVIDIA MEDICAL GMBH U CO KG | Emmingen-Liptingen Baden-Wurttemberg, DE |
| 9616088 | Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, MX |
| 8040881 | MEDISPOREX (PVT) LTD. | SIALKOT Punjab, PK |
| 9616250 | ASANUS MEDIZINTECHNIK GMBH | NEUHAUSEN OBECK Baden-Wurttemberg, DE |
3015895045 when referencing this establishment in official correspondence.