Phillips Precision Inc

FDA Device Registration & Listing · Elmwood Park, NJ, US · Registration 3003387384

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
3003387384
FEI Number
3003387384
Entity Name
Phillips Precision Inc
City/State/Country
Elmwood Park, NJ, US
Establishment Address
7 Paul Kohner Pl, Elmwood Park, NJ 07407, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Phillips Precision Inc/Creighton (Owner Number: 10042522)
Owner / Operator Contact Address
7 Paul Kohner Place, Elmwood Park, NJ 07407, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Captiva Arthrex K2M K2M Orthofix Stry Mah DJO Stryker Cork Zimmer War Captiva Spine K2M Captiva Orthofix Stryker Cork Stry Mah Stryker Cork Captiva DJO Stry Mah Zimmer War Stryker Cork Stry Mah Stry Mah AM Surgical Aptis DJO K2M K2M SeaSpine FORZA Spacer System Stry Mah Captiva Stry Lim Stry Mah Stry Mah DJO Captiva Stryker Cork Zimmer War Orthofix Orthofix DJO Aptis Orthofix Stryker Mako Aptis Integra/SeaSpine Stry Lim Stry Mah DJO Stryker Mahwah Integra/SeaSpine Stry Mah Stry Mah Stry Lim Zimmer War Captiva K2M Stry Mah Spineology Orthofix Integra/SeaSpine Orthofix Aptis Stryker Mako Stryker Mahwah Stry Mah Stry Mah Captiva K2M Orthofix K2M DJO Zimmer War

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2013-12-04
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2015-05-15
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-12-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-12-04
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2012-12-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-12-13
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2013-12-04
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2015-05-15
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2022-03-25
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2022-03-25
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2022-03-25
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2022-03-25
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2022-03-25
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2022-03-25
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2022-03-25
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-13
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2012-12-13
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2012-12-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-12-04
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-12-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-13
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2014-12-04
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2023-06-22
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2013-12-04
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2014-12-04
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2014-12-04
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2014-12-04
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2014-12-04
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-12-04
HTF Curette General, Plastic Surgery Class 1 878.4800 2013-12-04
HWB Extractor Orthopedic Class 1 888.4540 2015-05-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2013-12-04
HWT Template Orthopedic Class 1 888.4800 2012-12-13
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-12-04
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2013-12-04
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2014-12-04
KXE Prosthesis, Wrist, Hemi-, Ulnar Orthopedic Class 2 888.3810 2012-12-05
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2015-05-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-12-04
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-12-04
HXB Probe Orthopedic Class 1 888.4540 2015-05-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-13
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-12-04
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2024-01-08
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-01-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-04
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2013-12-04
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2013-12-04
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-12-04
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2015-05-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2015-05-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-12-04
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2014-12-04
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2014-12-04
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2014-12-04
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2014-12-04
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2014-12-04
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2014-12-04
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2014-12-04
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2014-12-04
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2012-12-13
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2012-12-13
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2012-12-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-13
HWA Impactor Orthopedic Class 1 888.4540 2015-05-15
HXX Screwdriver Orthopedic Class 1 888.4540 2012-12-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-04-08
KXE Prosthesis, Wrist, Hemi-, Ulnar Orthopedic Class 2 888.3810 2012-12-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-05-15
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-12-04
LGE Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing Orthopedic Class 2 888.3530 2013-12-04
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2013-12-04
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 2015-05-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2014-12-04
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2014-12-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-05-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2015-05-15
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2013-12-04
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2012-12-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-12-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-12-04
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-12-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-12-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-13
HWX Tap, Bone Orthopedic Class 1 888.4540 2015-05-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-13
KXE Prosthesis, Wrist, Hemi-, Ulnar Orthopedic Class 2 888.3810 2013-12-04
NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Orthopedic Class 2 888.3535 2015-05-15
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2015-05-15
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2016-12-15
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2016-12-15
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2013-12-04
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-12-04
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-12-04
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-12-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-12-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-12-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-12-13
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-12-04
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-12-04
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2015-05-15
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2012-12-13

Official Correspondent

Shalyn Creighton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Phillips Precision Inc/Creighton
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
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K192492 Astura Medical, LLC EL CAPITAN Anterior Lumber Interbody System 2020-04-21
K212498 Nexus Spine, LLC Stable-L Standalone Lumbar Interbody System 2022-03-18
K041888 Signus Medizintechnik GmbH CURVED PEEK TETRIS SPINAL IMPLANT 2004-08-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003387384. Last updated year: 2026. Please use registration number 3003387384 when referencing this establishment in official correspondence.
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