MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H12mm

Registration Details

Registration Name: SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Registration Number: 3016443334
FEI Number: 3016443334
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: SURVEY NO-1540, BESIDE TORRENT PHARMA,, AHMEDABD-MEHSANA HIGHWAY, VILLAGE-RAJPUR
City: KADI Gujarat
Country: IN

Regulatory Submissions

510(k) Number: K192863

Owner / Operator

Firm Name: SOLCO BIOMEDICAL CO
Operator Number: 10077960
Address: 5 & 6, 3rd Floor, B. Jadav Chambers,, Ashram Road
City: AHMEDABAD
State: Gujarat
Postal Code: 380009
Country: IN

US Agent

Business Name: Carrasco
Contact Name: Mateo Carrasco
Address: 1815 Barker drive
City: Winter Park
State: FL
ZIP: 32789
Country: US
Email: [email protected]
Phone: 407 2849480

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	Class 2	Orthopedic	No	2021-05-14

Proprietary Names

MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H12mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H13mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H14mm 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, W9xL26, H12mm 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, H13mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H14mm W9xL22, 12Deg,H7/H8/H9/H10/H11/H12/H13/H14/H15/H16 ALIF Trial, LARGE(W39xL26), A12XH9/H11/H13/H15/H17H/H19 CAGE IMPACTOR- FLAT W11xL22, 12Deg, H7/H8/H9/H10/H11/H12/H13/H14/H15/H16 MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H11mm 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, W9xL26, H7mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H8mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H9mm Intervertebral fusion device with bone graft, lumbar TRIAL INSERTER MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H11mm Curette, Size 2, Straight MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL26, H15mm MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H16mm ALIF Trial, LARGE(W39xL26), A9XH9/H11/H13/H15/H17H/H19 W11xL22, 6Deg, H7/H8/H9/H10/H11/H12/H13/H14/H15/H16 MONDRIAN PLIF Cage, Straight, Titanium, 6 Deg, W9xL22, H10mm TRIAL STOPPER H15-17 CEZANNE-MONDRIAN, TL CURVED ARTICULATING INSERTER Inserter, Cage, Short Drill Tip, L20mm ALIF DTS Guide, H19 mm ALIF DTS Guide, H13 mm W9xL22, 6Deg,H7/H8/H9/H10/H11/H12/H13/H14/H15/H16 TRIAL STOPPER H19-21 ALIF Trial, LARGE(W39xL26), A15XH9/H11/H13/H15/H17H/H19 CAGE INSERTER TRIAL STOPPER H9-13 Curette, Size 4, Up-Biting Curette, Size 4, Straight Modular Flex Tip Driver, 1/4" QC OL Inserter, Cage, SM, Standard Inserter, Cage, Standard Plate Inserter Tip Curette, Size 6, Straight Locking Cap Driver, T15 Awl with Sleeve, Straight Plate Assembly Driver, T20 LUMBAR DISTRACTOR Curette, Size 4, Serrated ALIF DTS Guide, H11mm Adjustable Drill, Straight, 1/4" QC Hexalobular Tip, T20-Short Removable Tip ALIF Rasp Screw Driver, 1/4" QC, T20 ALIF DTS Guide, H17 mm Curette, Size 2, Down-Pushing Awl with Sleeve, Angled ALIF Bone Tamp ALIF DTS Guide, H21 mm Curette, Size 2, Up-Biting Angled Driver, 1/4" QC Hexalobular Tip, T20-Standard Modular Inserter, Cage/Plate TWO HANDED VERTEBRAL PREP HANDLE ALIF DTS Guide, H15 mm

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)