Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016443334

FEI Number

3016443334

Entity Name

SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

City/State/Country

KADI Gujarat, IN

Establishment Address

SURVEY NO-1540, BESIDE TORRENT PHARMA,, AHMEDABD-MEHSANA HIGHWAY, VILLAGE-RAJPUR, KADI Gujarat 382715, IN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

SOLCO BIOMEDICAL CO (Owner Number: 10077960)

Owner / Operator Contact Address

5 & 6, 3rd Floor, B. Jadav Chambers,, Ashram Road, AHMEDABAD, IN-GJ 380009, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Site Prep Removal Tool Site Prep Locator-Flat Series Site Prep Locator-Teeth Series Site Prep Impactor TiLink-P Inserter main Body TiLink-PJoint Rasp TiLink-P Inserter Threaded Rod Assembly- 30 mm Site Prep Adjustable Guide TiLink-P Drill Guide Dilator Assembly TiLink-P Screw Drill Bit 30 mm Drill Guide Adjustable Extension + 0mm Drill Guide Adjustable Extension + 2mm Site Prep Adjustable Guide Extension + 2 mm Impactor- No Guidewire Site Prep Rasp TiLink-P Inserter Hexalobe Driver Site Prep Adjustable Guide Extension + 4 mm Facet Screw inserter-AO T- Handle CURVED TLIF CAGE INSERTER, VALEO II PL/OL INNER SHAFT VALEO-II, TL CURVED ARTICULATING INSERTER K-Wire Holder Intervertebral Fusion Device With Bone Graft, Lumbar Lumbar Mallet - REV A Lumbar Mallet OL Trial 9x29 8-13 mm 0 DEGREE int shaft ORTHOPAEDIC SURGERY INSTRUMENTS- DEPTH GAUGE Cervical plate inner tray MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H11mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H12mm CEZANNE-MONDRIAN, TL CURVED ARTICULATING INSERTER MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H7mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H11mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H9mm Intervertebral fusion device with bone graft, lumbar CAGE INSERTER TRIAL STOPPER H19-21 TRIAL STOPPER H15-17 MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H16mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H8mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H12mm W9xL22, 6Deg,H7/H8/H9/H10/H11/H12/H13/H14/H15/H16 MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H15mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H10mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H10mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H13mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H15mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H16mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H9mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H7mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H14mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H8mm W11xL22, 6Deg, H7/H8/H9/H10/H11/H12/H13/H14/H15/H16 OL Inserter, Cage, SM, Standard TRIAL STOPPER H9-13 ALIF Trial, LARGE(W39xL26), A9XH9/H11/H13/H15/H17H/H19 MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H13mm Inserter, Cage, Standard MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H14mm CAGE IMPACTOR- FLAT W11xL22, 12Deg, H7/H8/H9/H10/H11/H12/H13/H14/H15/H16 TRIAL INSERTER Drill Tip, L20mm Modular Flex Tip Driver, 1/4" QC W9xL22, 12Deg,H7/H8/H9/H10/H11/H12/H13/H14/H15/H16 ALIF DTS Guide, H17 mm Screw Driver, 1/4" QC, T20 ALIF DTS Guide, H13 mm Inserter, Cage, Short Hexalobular Tip, T20-Short ALIF Trial, LARGE(W39xL26), A12XH9/H11/H13/H15/H17H/H19 Curette, Size 2, Down-Pushing ALIF Trial, LARGE(W39xL26), A15XH9/H11/H13/H15/H17H/H19 Plate Inserter Tip ALIF DTS Guide, H19 mm Curette, Size 2, Straight Curette, Size 2, Up-Biting Adjustable Drill, Straight, 1/4" QC Curette, Size 6, Straight ALIF Bone Tamp Modular Inserter, Cage/Plate ALIF Rasp Awl with Sleeve, Angled LUMBAR DISTRACTOR ALIF DTS Guide, H11mm Plate Assembly Driver, T20 ALIF DTS Guide, H21 mm Locking Cap Driver, T15 TWO HANDED VERTEBRAL PREP HANDLE Curette, Size 4, Serrated Curette, Size 4, Up-Biting Curette, Size 4, Straight ALIF DTS Guide, H15 mm Awl with Sleeve, Straight Removable Tip Angled Driver, 1/4" QC Hexalobular Tip, T20-Standard MIS SCREW TAP Goblin and Goblin LS Pedicle Screw Systems OPE SCREW TAP ORTHOPAEDIC SURGERY INSTRUMENTS- BENDING INSTRUMENT, COUNTOURING ORTHOPAEDIC SURGERY INSTRUMENTS-BONE MILL DRILL BIT D2.5 L12 MM ORTHOPAEDIC SURGERY INSTRUMENTS-IMPACTOR 2 Hole Plate Lateral Grabber, Med CERVICAL AWL, STRAIGHT, L14mm CERVICAL AWL, BENT, L16mm Plate Holder, 4 Holes Modular Handle CERVICAL AWL, STRAIGHT, L16mm Awl with Sleeve Intervertebral fusion device with bone graft, Cervical Modular Flex Tip Driver, AO QC, Long DTS GUIDE, 2 Holes, Adjustable, (SMALL & MEDIUM) HEXALOBULAR DRIVER, T10 SMALL AO QC - SELF RETAINING DTS Guide, 4 Holes CERVICAL AWL, BENT, L14mm Plate Holder, 2 Holes, Mid-line MODULAR HANDLE ADAPTER 2 Hole Plate Lateral Grabber DTS Guide, 2 Holes, Adjustable (Small & Medium) Angled AO Driver Shaft ORTHOPAEDIC SURGERY INSTRUMENTS-ACCESSORIES FIXATION, SPINAL INTERVERTEBRAL BODY Threaded Knob Extended Tab Pusher - Bar End Set Screw Inserter Low Top Pusher - Bar End Cannulated Screw Inserter Shaft Pusher Bar Shaft Outer Sleeve Bone Screw Inserter Driver, Cannulated ARMS WELDMENT, PUSH ARM ARMS WELDMENT, ROD ARM Retention Sleeve Set Screw Tightener Tower Modular Tulip Inseter quick connect carrier Reduction Pusher - Bar End Tightener Sleeve Digital Insert Assembly NAVIGATION DRIVER, T25, STANDARD NON-CANNULATED ORTHOPAEDIC SURGERY INSTRUMENTS- ACCESSORIES, ARTHROSCOPIC Dual Set Screw Starter Rod Template MIS ROD INSERTER ASSEMBLY ORTHOPAEDIC SURGERY INSTRUMENTS-FORK Intervertebral fusion device with bone graft, lumbar Remover Tamp, H9~16 COLLET TIGHTENER RODIN Disc Shaver, 12mm RODIN Trial, 6 degree, W30xL25, H14mm RODIN Trial, 6 degree, W30xL25, H12mm Expansion Driver, 1/4" QC, Lever RODIN Disc Shaver, 10mm Freehand Tamp RODIN Disc Shaver, 14mm Expansion Driver RODIN Trial, 6 degree , W27xL21, H14mm RODIN Box Cutter, 10 mm RODIN Trial, 6 degree, W30xL25, H8mm RODIN Trial, 6 degree , W27xL21, H9mm RODIN Disc Shaver, 13mm Expansion Driver, 1/4" QC, Impactor Lever RODIN Trial, 6 degree, W30xL25, H10mm SHORT BLUNT DISTRACTOR, H9mm, 1/4" QC Box Cutter Strike Plate RODIN Trial, 6 degree , W27xL21, H12mm Rodin Inserter RODIN Disc Shaver, 8mm RODIN Disc Shaver, 7mm Initial Paddle Distractor RODIN Box Cutter, 8 mm Inserter Collet Expansion Tamp Implant Inserter, Lever RODIN Disc Shaver, 9mm RODIN Trial, 6 degree, W30xL25, H9mm CEZANNE-MONDRIAN, TL CURVED ARTICULATING INSERTER Remover Collet Impactor RODIN Trial, 6 degree W27xL21, H10mm Plunger, Graft Delivery Device SHORT BLUNT DISTRACTOR, H8mm, 1/4" QC SHORT BLUNT DISTRACTOR, H10mm, 1/4" QC RODIN Trial, 6 degree , W27xL21, H11mm RODIN Box Cutter, 9 mm T-HANDLE, QC, SQ, M5 RODIN Trial, 6 degree, W30xL25, H13mm RODIN Trial, 6 degree , W27xL21, H13mm RODIN Preliminary Annulotomy Cutter GRAFT DELIVERY DEVICE RODIN Disc Shaver, 11mm Freehand Tamp, Bent Remover Tamp, H6~12 RODIN Trial, 6 degree, W30xL25, H11mm Rodin Implant Inserter Lateral Connector, D6.35 Tulip Head, Round, L20mm Domino Connector, L16mm, D1=6.35, D2=6.35 Cross Connector 70mm Axial Connector, L40mm , D6.35 to D6.35 Lateral Connector, D6.35 Tulip Head, Round, L50mm Domino Connector, L18mm, D1=6.35, D2=6.35 Cross Connector 55mm Cross Connector 90mm Lateral Connector, D6.35 Tulip Head, Round, L25mm Cross Connector 45mm APPLIANCE, FIXATION , SPINAL INTERLAMINAL Cross Connector Screwdriver French Rod bender VALEO II PL/OL INNER SHAFT Valeo II PL/OL Inserter Inner Shaft Slap Hammer ORTHOPAEDIC SURGERY INSTRUMENTS-REAMER 4CIS BLACK MARLIN PLIF CAGE SYSTEM 4CIS DOLPHIN TLIF CAGE SYSTEM TiLink-L Navigation Impact Cap Valeo II Inserter Sleeve VALEO II PL/OL INNER SHAFT VESPER INSTRUMENT REMOVAL TOOL- METAL VESPER SERRATED RASP- LARGE VESPER FACET LOCATOR VESPER GRAFT TAMP VESPER 5.5 MM DRILL BIT VESPER IMPACTOR VESPER INSERTER THREADED ROD VESPER DRILL GUIDE - 90 DEGREE BARBS VESPER INSERTER MAIN BODY MATISSE ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H7mm ACIF TRIAL- W 14x L12, 6 DEG, H5/ H6 MATISSE ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H8mm MATISSE ACIF Cage ACIF TRIAL- W17 x L14, 6 DEG, H7/H8 ACIF TRIAL- W 14x L12, 6 DEG, H9/ H10 ACIF TRIAL- W17 x L14, 6 DEG, H9/H10 MATISSE ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H10mm MATISSE ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H9mm MATISSE ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H8mm ACIF TRIAL- W 14x L12, 6 DEG, H7/ H8- MATISSE ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H7mm ACIF TRIAL- W17 x L14, 6 DEG, H5/H6 MATISSE ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H9mm MATISSE ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H10mm Pistol Grip Reducer Axial Rod Reducer Screw to Screw Distractor Assembly Plate Holder, 4 Holes CERVICAL AWL, BENT, L14mm Intervertebral fusion device with bone graft, Cervical CERVICAL AWL, STRAIGHT, L14mm DTS GUIDE, 2 Holes, Adjustable, 2 Hole Plate Lateral Grabber, Med CERVICAL AWL, BENT, L16mm Modular Handle HEXALOBULAR DRIVER, T10 SMALL AO QC - SELF RETAINING Plate Holder, 2 Holes, Mid-line DTS Guide, 4 Holes MODULAR HANDLE ADAPTER CERVICAL AWL, STRAIGHT, L16mm Awl with Sleeve ORTHOPAEDIC SURGERY INSTRUMENTS-BIT, DRILL ORTHOPAEDIC SURGERY INSTRUMENTS-CORKSCREW PL OL Inserter T-Handle Drill Guide, FA Drill Guide, VA Caliper, 0-120mm Valeo II TL Slim Straight Positioner Valeo II TL, Nt Slim Str Pos Locking Plate Driver Shaft, AO Male QC Valeo II TL Fixed Inserter PL OL Inserter Inner Shaft Plate Holding Forceps Plate Bender (for NEW Van Gogh Plates) Spinal Vertebral Body Replacement Device ORTHOPAEDIC SURGERY INSTRUMENTS- APPLIER, CERCLAGE 4CIS SARA SPINE SYTEM 4CIS VERTU SPINE SYSTEM ORTHOPAEDIC SURGERY INSTRUMENTS-TEMPLATE MODULAR RASP INSERTER 5 mm Drill Bit-7 mm 5.5 mm Drill Bit-7 mm Facet locator- 7 mm Impactor- 7 mm 4.5 mm Drill Bit-7 mm Dilator, ID 10 x OD 14 mm, L 180, R, Sight Window APPLIANCE, FIXATION , SPINAL INTERLAMINAL PERSUADER, GUN-STYLE- INNER TUBE Knob Adapter Inserter, Set Screw, Expandable PERSUADER, GUN-STYLE HEXALOBE DRIVER, SELF-RETAINING, CANNULATED, T25, SHORT Screw, Pedicle DL Cannulated, 5.5x55mm Driver Headless 10in Final Tightening Driver T30 7mm HEX Screwdriver, Adjustment/Removal, T25 SCREW TO SCREW DISTRACTOR Spring Cage Screw, Pedicle DL 7.5x60mm Rod Bender In-Situ Right Persuader, Tower Driver Polyaxial Long Driver, Headless, 10 in Screw, Pedicle DL Cannulated, 8.5x50mm Persuader Tower Adapter Head Inserter Headbody, Assembly, Reduction Tap Double Lead 5.5mm Driver Adjustment / Removal T25 Driver, Polyaxial, Long Probe Sounder Curved Headbody, Assembly, Reduction(Cat No - C51-1000-002) Tap Double Lead 7.5mm(Cat No - C50-2000-075) Cross Connector, 70mm(Cat No - C10-2900-070) Screw, Dual Lead, 6.5mm x 35-50 mm Tap Double Lead 4.5mm Screw, Dual Lead, 9.5mm x 35-100 mm SET SCREW M6 X 0.5 L5 Screw, Dual Lead, 7.5mm x 35-55 mm Cross Connector, 70mm Tap, Double Lead, 5.5mm Screw, Dual Lead, 8.5mm x 35-110 mm Tap, Double Lead, 4.5mm Rod Bender In-Situ Left Screw, Dual Lead, 5.5mm x 30- 55 mm Rod Forceps, Long, 5.5mm Cross Connector, 90mm HANDLE COLOR(Cat No - C50-7000-002) Probe Sounder Straight(Cat No - C50-2000-002) Final Tightening Driver,T30, 7mm HEX Screw, Pedicle DL Cannulated, 6.5x45mm SCREW, PEDICLE, DOUBLE LEAD, FLUTELESS DIA 6.5mm x 30-60 mm LONG Tap Double Lead 6.5mm(Cat No - C50-2000-065) Rod Forceps Long 5.5mm Cross Connector, 45mm(Cat No - C10-2900-045) Probe, Sounder, Straight Probe, Sounder, Curved Inserter Set Palm T30 HANDLE Rod Bender, In-Situ, Left Screw, Pedicle DL Cannulated, 6.5x55mm SCREW, PEDICLE, DOUBLE LEAD, FLUTELESS DIA 7.5mm x 40-50 mm LONG Saddle Rod Gripper Slimline 5.5mm(Cat No - C27-4000-091) Probe Sounder Straight Tap Double Lead 6.5mm Probe Sounder Curved(Cat No - C50-2000-001) Tap, Double Lead, 8.5mm Driver Polyaxial Reduction Long Persuader, Tower, Adapter Tap Double Lead 8.5mm Cross Connector, 55mm Rod Bender, In-Situ, Right Rod Gripper Slimline 5.5mm K-Wire Driver TRIAL SCREW Tap Double Lead 4.5mm(Cat No - C50-2000-045) Driver Polyaxial Reduction Long(Cat No - C50-3000-009) Cross Connector, 45mm Cross Connector, 55mm(Cat No - C10-2900-055) SCREW, PEDICLE, DOUBLE LEAD, FLUTELESS DIA 5.5mm x 40-55 mm LONG Screw Distractor Screw, Pedicle DL Cannulated, 7.5x50mm Persuader Tower Adapter(Cat No - C50-6000-005) Tap Double Lead 5.5mm(Cat No - C50-2000-055) Tap, Double Lead, 7.5mm Set screw, T30 Head Reamer K-Wire_Driver Set screw, T30(Cat No - C51-0000-000) Inserter, Set-Screw, Double-Sided(Cat No - C50-7000-001) Screw, Pedicle DL Cannulated 5.5x30mm Tap Double Lead 7.5mm Inserter Set Palm T30(Cat No - C50-7000-002) SET SCREW M6 X 1 L5 Inserter, Set-Screw, Double-Sided Tap, Double Lead, 6.5mm Screw, Pedicle DL Cannulated, 7.5x55mm Screw, Dual Lead, 6.5mm x 60mm Screw, Pedicle DL Cannulated, 7.5x40mm Tap Double Lead 8.5mm(Cat No - C50-2000-085) Cross Connector, 90mm(Cat No - C10-2900-090) MATISSE ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H7mm ACIF TRIAL- W17 x L14, 6 DEG, H9/H10 ACIF TRIAL- W17 x L14, 6 DEG, H7/H8- Rev A MATISSE ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H8mm ACIF TRIAL- W 14x L12, 6 DEG, H9/ H10 MATISSE ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H8mm ACIF TRIAL- W 14x L12, 6 DEG, H7/ H8- Rev A MATISSE ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H10mm ACIF TRIAL- W17 x L14, 6 DEG, H5/H6 MATISSE ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H7mm MATISSE ACIF Cage, Titanium-PEEK - W17 x L14, 6Deg., H9mm MATISSE ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H10mm MATISSE ACIF Cage, Titanium-PEEK - W14 x L12, 6Deg., H9mm ORTHOPAEDIC SURGERY INSTRUMENTS- PUSHER SOCKET ORTHOPAEDIC SURGERY INSTRUMENTS- COUNTERSINK Cervical cage inner tray 1 Bone Curette(3mm) Tilink-P Instrument Removal Tool Rocker Arm, Housing Top Tap, Cortical, Cannulated, 4.5mm Modular Screw Body, T25, D4.5xL40mm Zero Step Screw Body, D6.5XL45-55 mm DEROTATOR Zero Step Screw Body, D4.5XL30mm Rod Reduction Housing MIS Access Tower, Segmented, Flexible Modular Screw Body, T25, D4.5xL25mm Modular Screw Body, T25, D4.5xL30mm K-wire Stylet, 55mm MIS Access Tube, Continuous, Flexible Tap, Cortical, 4.5mm Zero Step Screw Body, D5.5XL45-55 mm Modular Screw Body, T25, D4.5xL35mm Rod to Rod Connector, 30, LARGE T-handle, SQ 15 Adaptor SQ 15 to 1/4" QC K-wire Stylet, 45mm Adaptor QC, 1/4" SQ Female Rod to Rod Connector, 0, SMALL Rod to Rod Connector, 0, LARGE K-wire Stylet, 65mm Rod to Rod Connector, 30, SMALL ORTHOPAEDIC SURGERY INSTRUMENTS- BONE TAP ORTHOPAEDIC SURGERY INSTRUMENTS-DISPENSER CEMENT Intervertebral fusion device with bone graft, lumbar Cage Impactor, Curved Draw Screw, M3 x 0.5, 6g Cage Impactor TLIF Cage Holder/Inserter ORTHOPAEDIC SURGERY INSTRUMENTS- DRIVER PROSTHESIS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2023-02-23
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-05-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-05-28
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2020-10-09
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-04-25
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-05-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-09-03
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2020-10-09
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2020-10-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-04-04
HWA	Impactor	Orthopedic	Class 1	888.4540	2020-10-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-05-14
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-05-14
LYQ	Accessories, Fixation, Spinal Intervertebral Body	Orthopedic	Class 1	888.4540	2020-10-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-09-08
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2023-09-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2023-09-08
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2025-03-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-04-02
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2020-10-08
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-01-07
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-01-07
HXE	Fork	Orthopedic	Class 1	888.4540	2020-10-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-05-14
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2021-05-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-08-03
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-08-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-08-03
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2022-08-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2022-08-03
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2021-05-14
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2021-05-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2021-05-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-05-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-07-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-07-23
HTO	Reamer	Orthopedic	Class 1	888.4540	2020-10-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-01-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2026-03-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-07-23
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-07-23
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2026-04-03
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-06-11
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2023-09-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2023-09-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-09-19
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-05-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2020-10-08
HWI	Corkscrew	Orthopedic	Class 1	888.4540	2020-10-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-06-24
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-06-24
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2021-05-14
HXN	Applier, Cerclage	Orthopedic	Class 1	888.4540	2020-10-08
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-02-20
HWT	Template	Orthopedic	Class 1	888.4800	2020-10-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-05-20
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-05-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-05-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-06-21
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2024-06-21
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2024-06-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-02-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2025-02-20
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2025-02-20
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2021-05-14
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2021-05-14
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2021-05-14
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2021-05-14
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-07-23
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2020-10-08
HWW	Countersink	Orthopedic	Class 1	888.4540	2020-10-08
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-04-25
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2024-04-25
OUR	Sacroiliac Joint Fixation	Orthopedic	Class 2	888.3040	2025-05-16
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-02-04
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2022-02-04
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-02-04
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-02-04
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-02-04
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2020-10-09
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2020-10-09
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-05-14
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2020-10-08

Official Correspondent

No official correspondent registered.

US Agent Details

Mateo Carrasco Business: Carrasco Email: mateo@afpharmaservice.com Phone: (407) 2849480

Related Public Records

Same Entity

SOLCO BIOMEDICAL CO

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
K173198	U&I Corporation	Facet Screw Fixation System	2018-01-03
K121850	Choicespine, LP	Typhoon(TM) Facet Screw Fixation System	2012-09-20
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2012	Osteomed, Lp 3885 Arapaho Rd Addison TX 75001	U	OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016443334. Last updated year: 2026. Please use registration number 3016443334 when referencing this establishment in official correspondence.