FLEX-CELL PRECISION, INC.

FDA Device Registration & Listing · Lancaster, PA, US · Registration 3010120135

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
3010120135
FEI Number
3010120135
Entity Name
FLEX-CELL PRECISION, INC.
City/State/Country
Lancaster, PA, US
Establishment Address
1151 S Duke St, Lancaster, PA 17602, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Flex-Cell Precision, Inc. (Owner Number: 10043308)
Owner / Operator Contact Address
1151 South Duke Street, Lancaster, PA 17602, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ODP - Intervertebral fusion device with bone graft, cervical

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 2022-01-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2022-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-12
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2025-01-17
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2025-01-17
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2025-01-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-17
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2022-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2022-01-12
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2022-01-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-12
QHP Vertebral Body Tethering System Unknown Class N N/A 2026-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-04
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2017-11-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-12
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2016-03-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-03-17
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2016-03-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-03-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-03-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-03-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-03-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-12-30
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2016-03-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-01-30
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2026-01-30
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-01-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-03-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-04-30
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-04-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-02-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-02-07
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2013-02-04
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-04
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2026-01-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-17
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2026-01-30
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-01-30
MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous Orthopedic Class 2 888.3358 2026-01-30
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-01-30
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-12-30
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2020-12-30
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2022-01-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-17
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2026-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-04
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-02-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2013-02-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-17
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-04
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2026-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-04
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2022-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-11-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2017-11-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-04
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2016-12-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-12-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-12-01

Official Correspondent

Anthony Fanning

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Flex-Cell Precision, 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
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
K032604 Co-Ligne AG GII SPINAL FIXATION SYSTEM 2004-01-20
K964304 Osteonics Corp. OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY 1997-01-17

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 3010120135. Last updated year: 2026. Please use registration number 3010120135 when referencing this establishment in official correspondence.
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