Data / Medical devices / United States / Pacific Instruments Inc.
Pacific Instruments Inc.: FDA-registered device maker in Honolulu, HI, United States, 1 510(k) clearance
Pacific Instruments Inc. is registered with the FDA (registration 3005641619) in Honolulu, HI, United States. It lists 77 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 17, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005641619
- Address
- 438 Hobron Lane Suite 204, Honolulu, HI, United States, 96815
- Owner or operator
- PACIFIC INSTRUMENTS, INC. (9084764)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- July 27, 2006
- Registered through
- 2027
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Accessories, Arthroscopic | NBH | 1 | Contract manufacturer | accessdata.fda.gov |
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | 2 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Interlaminal | KWP | 2 | Contract manufacturer | accessdata.fda.gov |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Bender | HXW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Contract manufacturer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Contract manufacturer | accessdata.fda.gov |
| Chisel, Surgical, Manual | FZO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Clamp | HXD | 1 | Contract manufacturer | accessdata.fda.gov |
| Countersink | HWW | 1 | Contract manufacturer | accessdata.fda.gov |
| Curette | HTF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Contract manufacturer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Contract manufacturer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 | Contract manufacturer | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Contract manufacturer | accessdata.fda.gov |
| Elevator | HTE | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Contract manufacturer | accessdata.fda.gov |
| Extractor | HWB | 1 | Manufacturer | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Contract manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Contract manufacturer | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Haploscope | HJT | 1 | Contract manufacturer, Specification developer | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Contract manufacturer | accessdata.fda.gov |
| Impactor | HWA | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Contract manufacturer | accessdata.fda.gov |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Contract manufacturer | accessdata.fda.gov |
| Knife, Orthopedic | HTS | 1 | Contract manufacturer | accessdata.fda.gov |
| Mallet | HXL | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Orthopedic Stereotaxic Instrument | OLO | 2 | Contract manufacturer | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Contract manufacturer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Contract manufacturer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Contract manufacturer | accessdata.fda.gov |
| Probe | HXB | 1 | Contract manufacturer | accessdata.fda.gov |
| Probe, Rectal, Non-Powered | EXX | 1 | Contract manufacturer | accessdata.fda.gov |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | 2 | Contract manufacturer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Contract manufacturer | accessdata.fda.gov |
| Rasp | HTR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Rasp, Nasal | KBA | 1 | Contract manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Manufacturer | accessdata.fda.gov |
| Retractor | GAD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Contract manufacturer | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Contract manufacturer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Contract manufacturer | accessdata.fda.gov |
| Rongeur, Manual | HAE | 2 | Contract manufacturer | accessdata.fda.gov |
| Sacroiliac Joint Fixation | OUR | 2 | Contract manufacturer | accessdata.fda.gov |
| Scissors, General, Surgical | LRW | 1 | Contract manufacturer | accessdata.fda.gov |
| Scissors, Nasal | KBD | 1 | Contract manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Contract manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tamp | HXG | 1 | Contract manufacturer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Contract manufacturer | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Contract manufacturer | accessdata.fda.gov |
| Template | HWT | 1 | Contract manufacturer | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Contract manufacturer | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer | accessdata.fda.gov |
| Wrench | HXC | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| February 17, 2022 | K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | HTY | Substantially Equivalent | Pacific Instruments | accessdata.fda.gov |
Compare with other makers
Updated February 17, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.