FDA Registration
Active
🇺🇸 United States
APS MATERIALS, INC.
Reg #: 1529009
·
FEI: 1000149660
·
Expires 2026
Products
47
Proprietary Names
42
Establishment Types
2
Classifications
47
Registration Details
- Registration Name
- APS MATERIALS, INC.
- Registration Number
- 1529009
- FEI Number
- 1000149660
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4011 RIVERSIDE DR.
- City
- DAYTON
- State
- OH
- ZIP
- 45405
- Country
- US
Owner / Operator
- Firm Name
- APS Materials, Inc
- Operator Number
- 9023611
- Address
- 4011 Riverside Dr, Dayton OH
- City
- Dayton
- State
- OH
- Postal Code
- 45405
- Country
- US
- Correspondent
- Chris Page
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-12-11 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2017-12-11 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2017-12-11 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2017-12-11 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-12-11 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2019-02-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2019-02-12 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2024-10-23 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2014-12-29 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2018-01-18 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2016-07-21 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2016-07-21 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2026-05-08 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2026-05-08 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2025-05-28 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2025-05-28 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2025-05-28 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2018-01-18 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2018-01-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2018-01-18 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2018-01-18 |
| Prosthesis, Hip, Femoral, Resurfacing | KXA | Class 2 | Orthopedic | No | 2019-07-16 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2016-07-20 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2020-07-29 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2026-05-08 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2016-07-20 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2017-12-11 |
| Joint, Temporomandibular, Implant | LZD | Class 3 | Dental | No | 2018-01-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2018-01-18 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive | PBI | Class 2 | Orthopedic | No | 2018-01-18 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2018-01-18 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2018-01-18 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2018-01-18 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2016-07-20 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2016-07-20 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | MBV | Class 2 | Orthopedic | No | 2019-07-15 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2018-01-18 |
| Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal | KWB | Class 3 | Orthopedic | No | 2018-01-18 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2018-01-18 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-07-20 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-12-11 |
Proprietary Names
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
PEK - Spinous process plate
Hip Prosthesis
ORTHOPEDIC SALVAGE SYSTEM- OSS
Comprehensive Reverse Shoulder
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Identity Shoulder System
KRO - PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
XR-SERIES BI-METRIC FEMORAL COMPONENTS
Prosthesis, hip, femoral, resurfacing
M/L Taper Hip Prosthesis
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
ONCOLOGY SALVAGE SYSTEM
KRO - PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER JDI - Prosthesis, hip, semi-constrained, me
PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Prosthesis, hip, semi-constrained, metal/polymer, cemented
Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
KWT - PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWS - PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, META
shoulder prosthesis, reverse configuration
prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
25MM Glenosphere Mini Baseplate w/HA
ULNA ASSY
Hip Stems
KWZ - Prosthesis, hip, constrained, cemented or uncemented, metal/polymer KWA - Prosthesis, hip, semi-constrained (meta
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS
Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer MBH - PROSTH
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
JDC - PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
KWS - PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWT - PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only