FDA Registration
Active
🇺🇸 United States
PACIFIC INSTRUMENTS INC.
Reg #: 3005641619
·
FEI: 3005641619
·
Expires 2026
Products
77
Proprietary Names
0
Establishment Types
3
Classifications
77
Registration Details
- Registration Name
- PACIFIC INSTRUMENTS INC.
- Registration Number
- 3005641619
- FEI Number
- 3005641619
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 438 Hobron Lane, Suite 204
- City
- Honolulu
- State
- HI
- ZIP
- 96815
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213982
Owner / Operator
- Firm Name
- PACIFIC INSTRUMENTS, INC.
- Operator Number
- 9084764
- Address
- 438 Hobron Lane, Suite 204
- City
- Honolulu
- State
- HI
- Postal Code
- 96815
- Country
- US
- Correspondent
- HOLGER - GRUENERT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-08-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-08-21 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2024-04-05 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-07-30 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2026-03-05 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2013-03-01 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-04-05 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2014-05-05 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2013-02-08 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2013-03-14 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-02-08 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2013-02-08 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-08-03 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2022-02-15 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2013-01-28 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2013-02-22 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2015-01-23 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-01-28 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2023-06-22 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2017-08-10 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2013-03-04 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-12-05 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2013-02-08 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2023-02-21 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2024-04-24 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2013-02-08 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2026-06-16 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2013-03-01 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2013-03-01 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2023-07-20 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2013-02-08 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2013-02-22 |
| Haploscope | HJT | Class 1 | Ophthalmic | No | 2026-01-15 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2022-12-05 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-02-22 |
| Probe | HXB | Class 1 | Orthopedic | No | 2013-04-10 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2023-11-15 |
| Template | HWT | Class 1 | Orthopedic | No | 2013-01-28 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-01-21 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2022-02-15 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-01-28 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2013-01-28 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2006-07-27 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-21 |
| Bender | HXW | Class 1 | Orthopedic | No | 2023-05-19 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-02-08 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2013-03-28 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-01-28 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-07-27 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2023-05-31 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2024-04-11 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2023-10-06 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2013-01-28 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2023-10-06 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2024-01-08 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2013-02-08 |
| Probe, Rectal, Non-Powered | EXX | Class 1 | Gastroenterology, Urology | No | 2013-04-12 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2013-02-08 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-06-30 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2013-01-21 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-01-21 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2023-09-13 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2023-11-14 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2023-09-19 |
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | Class 1 | Orthopedic | No | 2023-07-27 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-05-07 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2013-02-13 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2013-03-18 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2024-01-29 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-01-28 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility