PRECISION FORMS, INC.

FDA Device Registration & Listing · Butler, NJ, US · Registration 3010041993

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
3010041993
FEI Number
3010041993
Entity Name
PRECISION FORMS, INC.
City/State/Country
Butler, NJ, US
Establishment Address
97 Decker Rd, Butler, NJ 07405, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Precision Forms, Inc. (Owner Number: 10043073)
Owner / Operator Contact Address
97 Decker Road, Butler, NJ 07405, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MRS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-01-23
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3510 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-23
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-23
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-01-23
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-01-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-23

Official Correspondent

William Sulski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Precision Forms, 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
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010041993. Last updated year: 2026. Please use registration number 3010041993 when referencing this establishment in official correspondence.
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