WESTWOOD PRECISION LLC

FDA Device Registration & Listing · Allentown, PA, US · Registration 3010120339

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
3010120339
FEI Number
3010120339
Entity Name
WESTWOOD PRECISION LLC
City/State/Country
Allentown, PA, US
Establishment Address
1530 E Race St, Allentown, PA 18109, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Westwood Precision LLC (Owner Number: 10043285)
Owner / Operator Contact Address
1530 East Race Street, Allentown, PA 18109, US
Initial Importer Flag
N
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-01-16
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2017-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-01-16
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2017-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-11-30
OUG Medical Device Data System General Hospital Class 1 880.6310 2013-02-02
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2015-05-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-11-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-05-18
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-05-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-05-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-05-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-05-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-05-18

Official Correspondent

Paul Sagun

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Westwood Precision LLC
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
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
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05

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 3010120339. Last updated year: 2026. Please use registration number 3010120339 when referencing this establishment in official correspondence.
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