FDA Registration
Active
🇺🇸 United States
NORWOOD MEDICAL LLC
Reg #: 1531174
·
FEI: 3002993297
·
Expires 2026
Products
51
Proprietary Names
44
Establishment Types
1
Classifications
51
Registration Details
- Registration Name
- NORWOOD MEDICAL LLC
- Registration Number
- 1531174
- FEI Number
- 3002993297
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2122 Winners Circle
- City
- Dayton
- State
- OH
- ZIP
- 45404
- Country
- US
Owner / Operator
- Firm Name
- Norwood Medical
- Operator Number
- 10042115
- Address
- 2122 Winners Circle
- City
- Dayton
- State
- OH
- Postal Code
- 45404
- Country
- US
- Correspondent
- Jennifer L Kleinwaechter
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-08-26 |
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2020-11-06 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-03 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-03 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-03 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-03 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-01-02 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2012-12-07 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-01-04 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2024-05-31 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-09-23 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2024-05-31 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2025-04-11 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2013-01-04 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-07 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2025-04-11 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-07 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2026-01-13 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2026-01-13 |
| Implant, Fixation Device, Spinal | JDN | Class 2 | Orthopedic | No | 2026-01-13 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2012-12-07 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-01-04 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2018-06-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2018-06-19 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2018-06-19 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2018-06-19 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2018-06-19 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2018-06-19 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2012-12-07 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2012-12-07 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2012-12-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2012-12-07 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2012-12-07 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2013-01-07 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2023-12-18 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-01-16 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-01-04 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2020-10-29 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-10-29 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-07 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2020-08-26 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2023-01-19 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2023-01-19 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-01-04 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2024-05-31 |
Proprietary Names
Locking Drill Guide 2.2mm
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES
Zimmer Persona Knee System
8mm Assist Cannula, 12mm Assist Cannula
Endo Wrist Stapler 45 and Stapler 45 Reloads
da Vinci Surgical System, Model IS5000
Zimmer Trabecular Metal Total Ankle
TI X25 Variable Connector Setscrew
Continuum, Trilogy IT Acetabular System Provisional Liner Locking Screw
Zimmer Segment System Trabecular Metal Proximal Tibial Component
Monoaxial Screw 5.5 x 5 X 30mm
Monoaxial Screw 5.5 x 5 X 35mm
Monoaxial Screw 5.5 x 6 X 50mm
Single Hole Staple
Monoaxial Screw 5.5 x 7 X 60mm
Monoaxial Screw 5.5 x 6 X 55mm
Dual Hole Staple, Rostral, Small
Dual Hole Staple, Caudal, Medium
Monoaxial Screw 5.5 x 6 X 27.5mm
Dual Hole Staple, Rostral, Medium
Monoaxial Screw 5.5 x 6 X 45mm
Monoaxial Screw 5.5 x 7 X 45mm
Crossconnector 13mm
Monoaxial Screw 5.5 x 6 X 37.5mm
Crossconnector 16mm
Monoaxial Screw 5.5 x 5 X 40mm
Monoaxial Screw 5.5 x 6 X 22.5mm
Crossconnector 18mm
Crossconnector 15mm
Crossconnector Set Screw
Crossconnector 14mm
Monoaxial Screw 5.5 x 6 X 40mm
Monoaxial Screw 5.5 x 7 X 30mm
Monoaxial Screw 5.5 x 7 X 50mm
Monoaxial Screw 5.5 x 7 X 25mm
Dual Hole Staple, Caudal, Small
Monoaxial Screw 5.5 x 6 X 32.5mm
Monoaxial Screw 5.5 x 7 X 35mm
Monoaxial Screw 5.5 x 6 X 30mm
Monoaxial Screw 5.5 x 6 X 35mm
Monoaxial Screw 5.5 x 7 X 40mm
Dual Hole Staple, Rostral, Large
Zimmer Persona Personalized Knee System
Bone Depth Gauge
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)