FDA Registration
Active
🇺🇸 United States
Jabil Inc. (Elmira)
Reg #: 3015440604
·
FEI: 3015440604
·
Expires 2026
Products
47
Proprietary Names
63
Establishment Types
1
Classifications
47
Registration Details
- Registration Name
- Jabil Inc. (Elmira)
- Registration Number
- 3015440604
- FEI Number
- 3015440604
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 35 Airport Road
- City
- Horseheads
- State
- NY
- ZIP
- 14845
- Country
- US
Owner / Operator
- Firm Name
- Jabil Inc.
- Operator Number
- 9074019
- Address
- 10800 Roosevelt Blvd.
- City
- Saint Petersburg
- State
- FL
- Postal Code
- 33716
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-04-30 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-04-30 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2022-03-31 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2019-03-08 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2019-03-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-04-29 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-04-29 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-04-29 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-04-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-01-15 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2019-04-29 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2019-04-30 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | KTW | Class 2 | Orthopedic | No | 2019-04-30 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-03-08 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-04-30 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2019-04-30 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-04-29 |
| External Mandibular Fixator And/Or Distractor | MQN | Class 2 | Dental | No | 2019-04-29 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2019-04-30 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2019-04-28 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2019-04-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2018-08-10 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2019-04-29 |
| Driver, Wire, And Bone Drill, Manual | DZJ | Class 2 | Dental | No | 2019-04-29 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2019-04-30 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2019-04-30 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2024-08-01 |
| Condylar Plate Fixation Implant | JDP | Class 2 | Orthopedic | No | 2024-08-01 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2019-04-29 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-08-26 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2019-04-29 |
| Drill, Bone, Powered | DZI | Class 2 | Dental | No | 2019-04-29 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2019-04-29 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | HSZ | Class 1 | General, Plastic Surgery | No | 2019-04-30 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-04-29 |
| Prosthesis, Condyle, Mandibular, Temporary | NEI | Class 2 | Dental | No | 2024-08-01 |
| Wire, Fixation, Intraosseous | DZK | Class 2 | Dental | No | 2024-08-01 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2024-08-01 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2019-04-30 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-03-08 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2018-08-14 |
| Cover, Burr Hole | GXR | Class 2 | Neurology | No | 2019-04-30 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2019-04-29 |
| Template | HWT | Class 1 | Orthopedic | No | 2019-04-29 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2018-08-10 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2019-04-30 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2018-08-10 |
Proprietary Names
Staple
Manual Orthopedic Instruments
Instrument
surgical instrument
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
CHIA PERCPASSER, DePuy Mitek Instrument
Synthes Dual-Opening USS
MODULAR FOOT SYSTEM - 2.7 MM MODULE
REAMER (MULTIPLE BRANDS)
VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
MANDIBLE EXTERNAL FIXATOR
LCP
Bit, Drill
SYNTHES (USA) LCP MODULAR FOOT PLATES
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
MR Conditional
DePuy Synthes Plates And Screws Portfolio
Depuy Synthes MAXFRAME Multi-Axial Correction System
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
LCP CURVED PLATES
MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK
HA COATED SCHANZ SCREWS
instrument
DePuy Synthes Maxillofacial Portfolio - MR Conditional
Stryker F1 Charger Module
Synthes Neuro Plate and Screw Syste
SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
Appliance Fix, Nail Blade Plate Com
SS Elastic IM Nail
TROCHANTERIC FIXATION NAIL (TFN)
USS
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
VOLT Locking and Cancellous Screws
VOLT Small Fragment Plating System
VOLT Mini Fragment Plating System
DePuy Synthes VOLT Mini Fragment Plating System
4.5 MM AND 6.5 MM HEADLESS COMPRESS
guide
Guide, Surgical Instrument
Guide Block
Drill Sleeve
SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
SYNTHES(USA) SYNTHES HYBRID EXTERNA
SYNTHES UNIVERSAL SPINAL SYSTEM
Synthes2.4 LCP Vol. Col. Dist. Radi
template
Ankle Trauma System
General Surgical
2.4mm Cannulated Screw
HA Coated Schanz Screw
SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM
SYNTHES USS (10MM SIDE OPENING SCREWS
Synthes Large Ex Fix, MR Cond.
Saw Blade
SYNTHES VA LCP ANKLE TRAUMA SYSTEM
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
DePuy Synthes 2.7mm VA LCP Clavicle Plate System
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
SYNTHES USS, CLICK`X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
Expedium, Synapse
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)