Data / Medical devices / United States / GLW, Inc.
GLW, Inc.: FDA-registered device maker in Englewood Cliffs, NJ, United States, 8 510(k) clearances
GLW, Inc. is registered with the FDA (registration 3014967149) in Englewood Cliffs, NJ, United States. It lists 23 device types. The FDA files 8 510(k) clearances under its listings, the newest dated January 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014967149
- Address
- 930 Sylvan Ave Ste 125, Englewood Cliffs, NJ, United States, 07632
- Owner or operator
- GLW, INC. (10058309)
- Roles
- Complaint file establishment, Repackager or relabeler, Specification developer
- First device listed
- August 20, 2018
- Registered through
- 2026
- Brand names listed
- APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 08mm - F3-1029-008, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 10mm - F3-1029-010, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 12mm - F3-1029-012, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 14mm - F3-1029-014, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 16mm - F3-1029-016, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 18mm - F3-1029-018, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 20mm - F3-1029-020, APOLLO Ankle Fracture Plates / 2.9mm / Locking Screw / 2.9 x 22mm - F3-1029-022 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Burr, Orthopedic | HTT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Countersink | HWW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Elevator, Ent | KAD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gouge, Surgical, General & Plastic Surgery | GDH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Guide, Drill, Ligament | LXI | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Surgical, Non-Powered | HAO | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Staple Driver | HXJ | 1 | Specification developer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 25, 2023 | K223847 | CREED Cannulated Screws | HWC | Substantially Equivalent | Glw, Inc. | accessdata.fda.gov |
| October 27, 2022 | K221489 | Artemis Proximal Femoral Nail System | HSB | Substantially Equivalent | Glw, Inc. | accessdata.fda.gov |
| March 11, 2022 | K213005 | Apollo Ankle Fracture Plating System | HRS | Substantially Equivalent | Glw Medical, Inc. | accessdata.fda.gov |
| February 19, 2021 | K201379 | Artemis Proximal Femoral Nail System | HSB | Substantially Equivalent | Glw, Inc. | accessdata.fda.gov |
| December 16, 2020 | K200291 | CREED Cannulated Screws | HWC | Substantially Equivalent | Glw Medical, Inc. | accessdata.fda.gov |
| September 14, 2020 | K200343 | FusionFrame Ring Lock System | KTT | Substantially Equivalent | Glw Medical Innovation | accessdata.fda.gov |
| July 5, 2013 | K123234 | ERMIS STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | Ermis Medizintechnik | accessdata.fda.gov |
| May 27, 2010 | K100857 | FUSION MEDICAL RING LOCK SYSTEM | KTT | Substantially Equivalent | John J Riccio | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Tray, Surgical
- All makers of Retractor
- All makers of Bit, Drill
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Orthopedic Manual Surgical Instrument
Updated January 25, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.