PACIFIC INSTRUMENTS INC.

FDA Device Registration & Listing · Honolulu, HI, US · Registration 3005641619

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005641619
FEI Number
3005641619
Entity Name
PACIFIC INSTRUMENTS INC.
City/State/Country
Honolulu, HI, US
Establishment Address
438 Hobron Lane, Suite 204, Honolulu, HI 96815, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
PACIFIC INSTRUMENTS, INC. (Owner Number: 9084764)
Owner / Operator Contact Address
438 Hobron Lane, Suite 204, Honolulu, HI 96815, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-08-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-08-21
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2024-04-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-07-30
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2026-03-05
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-03-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-04-05
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2014-05-05
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2013-02-08
HXL Mallet General, Plastic Surgery Class 1 878.4800 2013-03-14
GAD Retractor General, Plastic Surgery Class 1 878.4800 2013-02-08
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-08
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2013-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-08-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-08-03
HXG Tamp Orthopedic Class 1 888.4540 2022-02-15
HWN Instrument, Compression Orthopedic Class 1 888.4540 2013-01-28
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-22
HAE Rongeur, Manual Neurology Class 2 882.4840 2015-01-23
HWA Impactor Orthopedic Class 1 888.4540 2013-01-28
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2023-06-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-07-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-07-05
HXC Wrench Orthopedic Class 1 888.4540 2017-08-10
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-03-25
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2013-03-04
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2013-01-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-12-05
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2013-02-08
GFC Driver, Surgical, Pin General, Plastic Surgery Class 1 878.4820 2023-02-21
HTS Knife, Orthopedic Orthopedic Class 1 888.4540 2024-04-24
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-02-08
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2026-06-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-03-26
HTR Rasp General, Plastic Surgery Class 1 878.4800 2013-01-28
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2013-03-01
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-03-01
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2023-07-20
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2013-02-08
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2013-02-22
HJT Haploscope Ophthalmic Class 1 886.1340 2026-01-15
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2022-12-05
HXX Screwdriver Orthopedic Class 1 888.4540 2013-02-22
HXB Probe Orthopedic Class 1 888.4540 2013-04-10
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2023-11-15
HWT Template Orthopedic Class 1 888.4800 2013-01-28
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-01-21
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-04-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-04-10
HTE Elevator General, Plastic Surgery Class 1 878.4800 2013-01-28
HWW Countersink Orthopedic Class 1 888.4540 2022-02-15
HWJ Awl Orthopedic Class 1 888.4540 2013-01-28
HTX Rongeur Orthopedic Class 1 888.4540 2013-01-28
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2006-07-27
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2013-01-21
HXW Bender Orthopedic Class 1 888.4540 2023-05-19
HTD Forceps General, Plastic Surgery Class 1 878.4800 2013-02-08
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2013-03-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-03-10
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2023-03-10
KTZ Caliper Orthopedic Class 1 888.4150 2013-01-28
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2006-07-27
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2013-01-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-09-08
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2023-05-31
HWX Tap, Bone Orthopedic Class 1 888.4540 2024-04-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-10-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-21
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2013-01-28
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2013-01-28
HXD Clamp General, Plastic Surgery Class 1 878.4800 2023-10-06

Official Correspondent

HOLGER GRUENERT

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PACIFIC INSTRUMENTS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09
K160980 Spineology, Inc. Threshold Pedicular Fixation System, Palisade Pedicular Fixation System 2016-05-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005641619. Last updated year: 2026. Please use registration number 3005641619 when referencing this establishment in official correspondence.
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