FDA Registration
Active
🇺🇸 United States
Orchid Orthopedic Solutions Alabama LLC
Reg #: 3009888740
·
FEI: 3009888740
·
Expires 2026
Products
85
Proprietary Names
91
Establishment Types
1
Classifications
85
Registration Details
- Registration Name
- Orchid Orthopedic Solutions Alabama LLC
- Registration Number
- 3009888740
- FEI Number
- 3009888740
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 331 City Park Dr SE
- City
- Arab
- State
- AL
- ZIP
- 35016
- Country
- US
Owner / Operator
- Firm Name
- Orchid Orhopedics
- Operator Number
- 10042268
- Address
- 331 City Park Dr. SE
- City
- Arab
- State
- AL
- Postal Code
- 35016
- Country
- US
- Correspondent
- Tim Ooten
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wrench | HXC | Class 1 | Orthopedic | No | 2014-06-13 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2020-09-21 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2020-10-21 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-10-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-31 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-31 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-12-12 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2013-01-31 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2015-02-27 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2015-02-27 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2015-12-31 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2023-01-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-01-13 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2021-11-30 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-11-30 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2012-12-10 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-01-31 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2012-12-12 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2012-12-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2023-01-13 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2023-01-13 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2021-02-11 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2021-02-11 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2024-03-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-12-12 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2019-01-28 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 2013-12-24 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2013-12-30 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2013-02-01 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2013-12-23 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2021-02-11 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2012-12-10 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2012-12-10 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2012-12-10 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2013-12-23 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2021-01-06 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2021-01-06 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2021-01-06 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2021-01-06 |
| Probe | HXB | Class 1 | Orthopedic | No | 2012-12-12 |
| Cradle, Patient, Radiologic | KXH | Class 1 | Radiology | No | 2013-12-30 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2024-10-17 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2012-12-12 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2013-01-31 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2014-02-03 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2013-01-31 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2012-12-03 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2015-12-31 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2012-11-07 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2012-12-12 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2024-11-08 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2016-12-28 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2013-12-24 |
| Prosthesis, Hip, Hemi-, Femoral, Metal Ball | LZY | Class 2 | Orthopedic | No | 2013-12-24 |
| Mesh, Surgical, Acetabular, Hip, Prosthesis | JDJ | Class 2 | General, Plastic Surgery | No | 2013-12-24 |
| Prosthesis, Hip, Femoral Component, Cemented, Metal | JDG | Class 2 | Orthopedic | No | 2013-12-24 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-12-24 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2013-12-24 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2013-12-24 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2013-12-24 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2012-12-12 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2012-12-12 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2012-12-12 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2012-12-12 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-12-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-12-24 |
| Bender | HXW | Class 1 | Orthopedic | No | 2012-12-12 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2013-12-23 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-11-07 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-12-12 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2012-12-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-11-06 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2012-12-12 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2013-12-23 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-17 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2016-12-28 |
| Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | KRQ | Class 2 | Orthopedic | No | 2012-12-27 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2012-12-27 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2012-12-12 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2014-12-29 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2013-01-31 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2014-06-13 |
Proprietary Names
Multiple
NAVIGATION ARRAY
BKS Revision Sleeves System
Zavation ALIF System
NovoKnee Total Knee System
SMR TT Metal Back Glenoid instrument set
Driver Handle
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
EVOS Screw
Verte-Stack Spinal System
Orthopedic stereotaxic instrument
Clydesdale Spinal System
Prosthesis, hip, semi-constrained, metal/polymer, cemented PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCE
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
Persona P-Ref Sizer
Persona P-REF Sizer Boom
Zimmer Trabecular Metal Total Ankle
Escalade Acetabular Cup System
Orchid- Othopedics
SpheRx II System
Peek Prevail Cervical Interbody Device
Acumed Cannulated Screw System
Stryker Tri-globe
Avance
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
EMPOWR 3D Knee
EMPOWR Porous Knee System
Quadrant Retractor System
302015120 ORTHOPEDIC STEREOTAXIC INSTRUMENT
302015020 ORTHOPEDIC STEREOTAXIC INSTRUCMENT
302015100 ORTHOPEDIC STEREOTAXIC INSTRUMENT
302015030 ORTHOPEDIC STEREOTAXIC INSTRUMENT
302015025 ORTHOPEDIC STEREOTAXIC INSTRUMENT
SMR Shoulder System
VuePoint OCT System
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MCK Baseplates
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Inserter
Orchid- Orthopedics
KeyLift Expandable Interlaminar Fusion System 6mm Rasp Trial (07-7000-006)
KeyLift Expandable Interlaminar Fusion System 8mm Rasp Trial (07-7000-008)
KeyLift Expandable Interlaminar Fusion System 12mm Rasp Trial (07-7000-012)
KeyLift Expandable Interlaminar Fusion System 10mm Rasp Trial (07-7000-010)
KeyLift Expandable Interlaminar Fusion System Inserter (07-7000-016)
Persona Partial Knee Instrument
Tiger 2 System
Paragon 28 APEX 3D Total Ankle Replacement System
Intrepid Spinal System
Perimeter Interbody Fusion Device
Zimmer Persona Personalized Knee System
Intervertebral fusion device with bone graft, lumbar
Smith and Nephew Modular Proximally Fluted Hip Stem
Capstone Spinal System
Biofoam
Clamp 7480760
Smith and Nephew Hip System
Prestige Cervical Disc System
Thoracolumbosacral pedicle screw system
Persona Revision
Medline Unite® Foot Plating System
Persona Revision Knee System
CD HORIZON® Spinal System Percutaneous Rod Inserter
CD Horizon Spinal System
T2 Sceptor Spinal System
Piccolo Composite Nailing System - Tibia and Femur
SMR 3-Pegs Glenoids
Embrace and Graft Containment Device
Saw Interface Left, Saw Interface Right, Array Clamp, Device Array Interface, Saw Interface Cleaning Cap
Escalade Legend Acetabular Shell
Orthopedic Stereotaxic Instrument 202000118
Pyramid Anterior Plate Fixation System
Zimmer Persona Knee System
302015100 ORTHOPEDIC STEREOTAXIC INSTRUMENT. ARTHROSCOPE
302015025 ORTHOPEDIC STEREOTAXIC INSTRUMENT. ARTHROSCOPE
302015030 ORTHOPEDIC STEREOTAXIC INSTRUMENT. ARTHROSCOPE
302015020 ORTHOPEDIC STEREOTAXIC INSTRUMENT. ARTHROSCOPE
iFuse
Soft Tissue Protector
Journey II Uni Resection Finishing Trial
Capstone R Spinal System
CD Horizon Sextant II
Fixion Nailing System
Gender Solutions Natural- Knee Flex Instruments
Cornerstone (R) PSR Cervical Fusion
AxiaLIF
Instrument Trays (All)
Journey Genesis
Unicompartmental and Bicompartmental Knee System Instruments
Smith and Nephew Total Knee System Instrumentation
Patient Position Support
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)