Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006791286

FEI Number

3006791286

Entity Name

ARCH MEDICAL SOLUTIONS - PHILADELPHIA, LLC DBA JADE PRECISION MEDICAL COMPONENTS

City/State/Country

Huntingdon Valley, PA, US

Establishment Address

3063 B Philmont Ave., Huntingdon Valley, PA 19006, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Arch Medical Solutions - Philadelphia, LLC DBA JADE PRECISIO (Owner Number: 10023130)

Owner / Operator Contact Address

3063 B Philmont Ave., Huntingdon Valley, PA 19006, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Polyaxial Osteo Screw 7.5mm Polyaxial Pedicle Screw 6.5 x XXmm Polyaxial Pedicle Screw 5.5 x XXmm Polyaxial Osteo Screw 8.5mm REVERE 6.35 Degen Ti System 3mm x XXmm Headless Screw 3mm x XXmm DPS Headless Screw 2.5mm x XXmm Headless Screw 6.5mm x XXmm Headless Screw 2mm x XXmm Headless Screw LineSider Spinal System Biased 360, 5.5/6 Closed Head WaveForm L System Cannulated Screw Assembly Set Screw Screw Assembly Nex-Gen Tibia 5 & 10mm Augment Screw Threaded Insert Ulnar Shortening Plates 10mm-16mm x 22mm LLIF Lordotic LLIF HH x WW x LL x XX DEG. Lordosis ZEUS-O OLLIF Cage 8-15mm x 9mm x 24-36mm LLIF-Parallel Assembly 4.5mm x XXmm Headed Screw 2.5mm x XXmm Headed Screw 4mm x XXmm Headed Screw X.5mm x XXmm Posted Shank Cannulated Precept 3Z Solid Screw Shank A.Amm x ZZmm MAS PLIF 3Z Solid Crew Shank A.Amm X ZZmm MAS PLIF Precept 3Z Polyaxial Screw Y.Y x ZZmm Implant, MotoBand CP, Non-Locking Screw 3.5mm Implant, MotoBand CP, Locking Screw 3mm Medial Column Distal Arch Plate, 2mm Thickness, Left, Small Medial Column Arch Plate, 1.5mm Thickness, Left, Large Medial Column Extended Arch Plate, 2mm Thickness, Left, Small Lisfranc, Dual Ray, 1ST & 2ND TMT Plate, Left, Small Lisfranc, Slanted Straight Plate, #-Hole, Slant Right Anatomic Fibular Plate, ## Hole, Right Lisfranc, Slanted-T, #-Hole Plate w/ Compression, Right Lisfranc, Slanted-T, #-Hole Plate w/ Compression, Left Lisfranc, Clover, #-Hole W/ Compression, Left Medial Column Extended Arch Plate, 2mm Thickness, Right, Medium Medial Column Distal Arch Plate, 2mm Thickness, Left, Medium Lisfranc, Dual Ray, 2ND & 3RD TMT Plate, Left, Medium MTP Plate, 5, Short-Short, Left, 2-Hole Distal Lisfranc, Dual Ray, 2ND & 3RD TMT Plate, Right, Large MTP Plate, 5, Short, Left Lisfranc, Dual Ray, 2ND & 3RD TMT Plate, Left, Large Medial Column Arch Plate, 2mm Thickness, Left, Small Medial Column Arch Plate, 1.5mm Thickness, Left, Small Lisfranc, Dual Ray, 1ST & 2ND TMT Plate, Right, Small Baby Gorilla, Plate, Straight, ## Hole Locking, #.#mm, TiA Lisfranc, Clover, #-Hole W/ Compression, Right Medial Column Distal Arch Plate, 2mm Thickness, Left, Large Lisfranc, Dual Ray, 2ND & 3RD TMT Plate, Right, Small MTP Plate, 0, Short-Short, Left, 2-Hole Distal Medial Column Extended Arch Plate, 2mm Thickness, Left, Large MTP Plate, 10, Medium, Left Lisfranc, Dual Ray, 1ST & 2ND TMT Plate, Right, Medium Lisfranc, Dual Ray, 1ST & 2ND TMT Plate, Left, Large Anatomic Fibular Plate, ## Hole, Left MTP Plate, 10, Short, Left Lisfranc, Slanted-T, 3-Hole Plate w/ Compression, Right Medial Malleolus Plate, 7-Hole, Anatomical Lisfranc, Dual Ray, 1ST & 2ND TMT Plate, Right, Large MTP Plate, 0, Medium, Left Medial Column Arch Plate, 2mm Thickness, Left, Large MTP Plate, 0, Short, Left Medial Column Extended Arch Plate, 2mm Thickness, Left, Medium Medial Column Arch Plate, 1.5mm Thickness, Right, Medium Lisfranc, Dual Ray, 2ND & 3RD TMT Plate, Right, Medium Lisfranc, Slanted-T, 3-Hole Plate w/ Compression, Left MTP Plate, 5, Graft Spanning, Left MTP Plate, 0, Long, Left MTP Plate, 5, Medium, Left Medial Column Extended Arch Plate, 2mm Thickness, Right, Small Lisfranc, Oblique L, 3-Hole Plate, Right Lisfranc, Dual Ray, 1ST & 2ND TMT Plate, Left, Medium Lisfranc, Oblique L, 3-Hole Plate, Left Medial Column Extended Arch Plate, 2mm Thickness, Right, Large Lisfranc, Slanted Straight Plate, #-Hole, Slant Left Medial Column Distal Arch Plate, 2mm Thickness, Right, Medium Implant, MIS Bunion Plate - Addtional Fixation Implant, MIS Bunion Plate Implant, MIS Bunion, 2.7mm Non-Locking Screw Implant, MIS Bunion, Polyaxial Locking Screw - 3mm Incorporate VBR, Peek Assembly .285 Solid Cancellous Shank X.X x YYmm Reline 5.5mm Open Tulip Lock Screw RMM Modular Tulip Assembly RMM XX.X x YYmm 4S Polyaxial Screw Reline Screw XX.X x YYmm 2S Reduction Reline Screw XX.X x YYmm 2F Polyaxial Reline MOD MAS Reduction Screw Tulip Reline Screw XX.X x YYmm 2S Ilian Closed Reline Screw XX.X x YYmm 2C Polyaxial Reline Screw XX.X x YYmm 2S Polyaxial Reline Screw X.X x YYmm Poly 2C MAS Reduction Reline Modular Tulip Assembly Reline Open Reduction Tulip, MOD CANN DRIVER BIT HEX 2.5MM AO SOLID DRIVER HEX 1.5MM AO SOLID DRIVER HEX 2.5MM AO CANN DRIVER BIT HEX 1.5MM AO SOLID DRIVER HEX 2MM AO CANN DRIVER BIT HEX 2MM AO Reline Cervical Tall Lockscrew Connector, X Reline Cervical Polyaxial Screw Assembly Y.Y x ZZmm Reline Cervical FA Partially Threaded Screw Y.Y x ZZmm Adjustable Occipital Plate Cross Connect Lockscrew, HEX Reline Cervical PA Screw Assembly Y.Y x ZZmm Extended Tab Tulip Body Prophecy Invision Guide Shim Threaded Insert NEX-GEN Tibia 5 & 10mm Augment Screw Implant Adjustment Screw 3-56 UNF, T8 HiJAK Cervical Cage Implant, Cannulated Bone Screw, Headless - 2.5mm Cervical Screw Variable Self Drilling Closed Polyaxial Screw XX.Xmm x XXXmm Cannulated Extended Tab Polyaxial Reduction Screw XX.Xmm x XXXmm Set Screw One Level Plate Geminus XL 3mm Bone Screw, Cannulated, Titanium, Headed RSS 2H In-Line CON, 4.5 - 6mm ROD RSS XX.X x YYmm 2S Uniplanar Screw RSS TGR Connector Assy XXmm Straight RSS 4H Parallel CON, 4.5 - 6mm ROD RSS XX.X x YYmm 2S Reduction Screw RSS 2H Parallel CON, 4.5 - 6mm ROD RSS 4H In-Line CON, 4.5 - 6mm ROD RSS XX.X x YYmm 2S Uni-Reduction Screw RSS X.X x YYmm 2S Monoaxial RSS XX.X x YYmm 2S Polyaxial Screw RSS Uni-Reduction Tulip Fragment Plate System Modulus ALIF Collet Apelo Assembled, GEMINUS Volar Distal Radius Plate, Narrow, 160 mm Geminus, Radial Mid Shaft Plate, 200 mm Assembled, GEMINUS Volar Distal Radius Plate, Narrow, 120 mm Assembled, GEMINUS, Volar Distal Radius Plate, Narrow, 200 mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-12-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-12-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-12-30
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-12-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-12-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2013-03-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-09
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-08-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-08-17
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-03-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-21
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-03
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2024-12-19
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-12-19
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-12-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-03-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2020-01-02
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-12-30
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-12-30
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-12-30
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-12-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-12-30
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-21
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-01-09
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-01-09
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-09-07
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-01-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-01-15
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2013-03-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-03
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-02
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2020-01-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-08-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-03-21
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2020-01-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2020-01-02
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2020-01-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-21
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-03-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2020-01-10
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2020-01-09
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2020-01-09
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-08-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-08-13
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-08-13
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-03-21
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-21
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-03-21
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2025-01-22
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-01-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-02
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-12-30
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2013-03-21
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-01-15
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-01-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2020-01-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2025-01-22
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2025-01-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-02
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-02
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-22
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-22
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2025-01-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-15
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2025-01-22
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2020-01-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2020-01-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2020-01-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-03

Official Correspondent

Yashkumar Patel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Arch Medical Solutions - Philadelphia, LLC DBA JADE PRECISIO

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
K032604	Co-Ligne AG	GII SPINAL FIXATION SYSTEM	2004-01-20
K964304	Osteonics Corp.	OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY	1997-01-17
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05

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-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).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006791286. Last updated year: 2026. Please use registration number 3006791286 when referencing this establishment in official correspondence.