Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009303371

FEI Number

3009303371

Entity Name

Variteks Ortopedi Sanayi A.S.

City/State/Country

Catalca Istanbul, TR

Establishment Address

Ferhatpasa Sb Mah. Menekse Sk., Variteks Blok No:3 Ic Kapi No:Z1, Catalca Istanbul 34540, TR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Variteks Ortopedi Sanayi A.S. (Owner Number: 10036107)

Owner / Operator Contact Address

Ferhatpasa Sb Mah. Menekse Sk., Variteks Blok No:3 Ic Kapi No:Z1, ?stanbul, TR-NOTA 34540, TR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CODE 210 PHILADELPHIA TRACHEOSTOMY COLLAR 855 Neo G RX Sacroiliac Belt (Sizes S - XL) CODE 901 THIGH HIGH VARICOSE STOCKING(OPEN TOE) CODE 907 PREGNANCY PANTYHOSE VARICOSE STOCKING(CLOSED TOE) CODE 963 PANTYHOSE VARICOSE STOCKING (OPEN TOE) CODE 917 PREGNANCY PANTYHOSE VARICOSE STOCKING (OPEN TOE) CODE 903 PANTYHOSE VARICOSE STOCKING(CLOSED TOE) CODE 911 THIGH HIGH VARICOSE STOCKING (OPEN TOE) CODE 902 KNEE HIGH VARICOSE STOCKING(OPEN TOE) 920 Neo G Mens Compression Socks (Sizes S - XXL) 923 Neo G Pantyhose Compression Hosiery (Sizes S - XXL) - Closed Toe CODE 932 KNEE HIGH VARICOSE STOCKING (CLOSED TOE) 921 Neo G Thigh High Compression Hosiery (Sizes S - XXL) - Closed Toe 922 Neo G Knee High Compression Hosiery (Sizes S - XXL) - Closed Toe 970 Neo G Travel & Flight Compression Socks (Sizes S - XL) 932 Neo G Energizing Daily Wear Knee Highs (Sizes S - XL) CODE 931 THIGH HIGH VARICOSE STOCKING (CLOSED TOE) 913 Neo G Pantyhose Compression Hosiery (Sizes S - XXL)- Open Toe 911 Neo G Thigh High Compression Hosiery (Sizes S - XXL) - Open Toe CODE 952 LYMPHEDEMA ARM SLEEVE CODE 951 LYMPHEDEMA ARM SLEEVE WITH BELT 912 Neo G Knee High Compression Hosiery (Sizes S - XXL) - Open Toe CODE 933 PANTYHOSE VARICOSE STOCKING (CLOSED TOE) 930 Neo G Energizing Daily Wear Men Socks (Sizes S - XL) CODE 904 THIGH HIGH VARICOSE STOCKING(CLOSED TOE) CODE 913 PANTYHOSE VARICOSE STOCKING (OPEN TOE) CODE 920 VARICOSE SOCKS FOR MEN CODE 912 KNEE HIGH VARICOSE STOCKING (OPEN TOE) 904 Neo G Thigh High Compression Hosiery (Sizes S - 4XL) - Closed Toe 972 Neo G Knee High Compression Hosiery (Sizes S - 4XL) - Open Toe 903 Neo G Pantyhose Compression Hosiery (Sizes S - 4XL) - Closed Toe CODE 905 KNEE HIGH VARICOSE STOCKING(CLOSED TOE) 905 Neo G Knee High Compression Hosiery (Sizes S - 4XL) - Closed Toe 971 Neo G Thigh High Compression Hosiery (Sizes S - 4XL) - Open Toe 973 Neo G Pantyhose Compression Hosiery (Sizes S - 4XL) - Open Toe 976 Neo G Comfort Socks (ankle sock style) 978 Neo G Comfort Socks (dress sock style) CODE 933SH PANTYHOSE SHEER VARICOSE STOCKING CODE 970 TRAVEL & FLIGHT COMPRESSION SOCKS CODE 930 ACTIVE SOCKS COMPRESSION SOCKS CODE 930ST ACTIVE SOCKS CLASSIC COMPRESSION SOCKS CODE 943 COMFORT SHEER PANTYHOSE STOCKING CODE 940 SPORTS SOCKS COMPRESSION SOCKS CODE 942 COMFORT SHEER KNEE-HIGH STOCKING CODE 941 COMFORT SHEER THIGH HIGH STOCKING CODE 931SH THIGH HIGH SHEER VARICOSE STOCKING CODE 932SH KNEE HIGH SHEER VARICOSE STOCKING CODE 976 COMFORT ANKLE SOCKS CODE 976 NEO G COMFORT ANKLE SOCKS CODE 119 PAVLIC BANDAGE CODE 188 ABDUCTION CORSET CODE 188 HIP ABDUCTION ORTHESIS CODE 656 VISCO TRAVEL PILLOW CODE 675 CYLINDER PILLOW CODE 651 VISCO ORTHOPEDIC NECK PILLOW CODE 652 VISCO ORTHOPEDIC NECK PILLOW CLASSIC CODE 653 VISCO ORTHOPEDIC NECK PILLOW ANATOMIC CODE 674 SEMI-CYLINDER PILLOW CODE 654 VISCO SEMI-CYLINDER PILLOW CODE 658 VISCO ANATOMIC BACK CUSHION (WITH BELT) CODE 655 VISCO CYLINDER PILLOW CODE 657 VISCO BACK CUSHION (WITH BELT) CODE 663 VISCO COCCYX SEATING CUSHION 998 Neo G Light Clavicle/Posture Support CODE 138 POSTUREX (CLAVICLE) CORSET 138 Neo G Clavicle Brace (POSTUREX) (Kids Size Available) CODE 118 CLAVICLE BANDAGE CODE 133 POSTOPERATIVE ABDOMINAL CORSET (20CM) CODE 260 NOSE GUARD MASK CODE 134 ELASTIC ABDOMINAL HERNIA CORSET CODE 139 ELASTIC PREGNANCY CORSET CODE 145 ELASTIC LIGHT LUMBOSTAD CORSET CODE 132 POSTOPERATIVE ABDOMINAL CORSET (28CM) CODE 570 SILICONE BREAST PROSTHESIS (PEAR-SYMMETRICAL) CODE 577 BRA FOR BREAST PROTHESIS CODE 652 VISCO ORTHOPEDIC NECK PILLOW CLASSIC CODE 163 TX KNEE BRACE WITH FLEXIBLE STAYS CODE 320 KNEE IMMOBILIZER CODE 651 VISCO ORTHOPEDIC NECK PILLOW CODE 884 KNEE SUPPORT CODE 885 OPEN KNEE SUPPORT CODE 655 VISCO CYLINDER PILLOW CODE 723 CALF SUPPORT CODE 898 HINGED STABILIZING KNEE BRACE 203 Neo G Soft Collar (S - XXL) (Kids Size Available) CODE 886 PATELLA BAND CODE 140 ELASTIC DORSOLOMBER CORSET (HEIGHT ADJUSTABLE) CODE 203 SOFT COLLAR CODE 206 NELSON COLLAR WITH CHIN SUPPORT CODE 888 THIGH SUPPORT CODE 204 NELSON COLLAR CODE 892 CALF SUPPORT CODE 250 MINERVA COLLAR CODE 653 VISCO ORTHOPEDIC NECK PILLOW ANATOMIC CODE 656 VISCO TRAVEL PILLOW CODE 202 CHIN SUPPORT COLLAR CODE 208 UNI-COLLAR SOFT CODE 802 ELASTIC TENDON BRACE 205 Neo G (205) Philadelphia Collar (S - L) (Kids Size Available) CODE 205 PHILADELPHIA COLLAR CODE 207 SOFT NELSON COLLAR CODE 201 SUPPORT COLLAR CODE 833 ARTICULATED KNEE STABILIZER 204 Neo G Nelson Collar (S - L ) (Kids Size Available) CODE 865 REFLEX AFO CODE 320 KNEE IMMOBILIZER CODE 863 DROP FOOT SUPPORT CODE 864 AFO (Foot guard) Code 735 - AIRFLOW REACT KNEE SUPPORT (S-M / L-XL) - Neo-G CODE 820 CLOSED KNEE SUPPORT CODE 804 JUDO KNEE BRACE 163 Neo G RX Stabilized Knee Support (Sizes S - XXL) CODE 886 PATELLA BAND CODE 725 KNEE SUPPORT CODE 898 HINGED STABILIZING KNEE BRACE CODE 823 KNEE BRACE WITH SPIRAL STAYS CODE 871 SPORT SHORT CODE 860 GENU RECURVATUM KNEE CAGE 884 Neo G Closed Knee Support CODE 828 HINGED STABILIZING KNEE BRACE CODE 834 CROSSED LIGAMENT KNEE SUPPORT CODE 858 HINGED STABILIZING KNEE BRACE (HEIGHT ADJUSTABLE) CODE 806 JUDO KNEE BRACE (LONG) 805 Neo G Knee Warmer & Support (Sizes S - XXL) CODE 454 KNITTED HINGED KNEE SUPPORT CODE 453 KNITTED FLEXIBLE KNEE SUPPORT 885 Neo G Open Knee Support (Kids Size Available) 725 Neo G Airflow Knee Support (Sizes S - XL) CODE 894 HINGED STABILIZING KNEE BRACE CODE 885 OPEN KNEE SUPPORT 893 Neo G Stabilized Open Knee Support 858 Neo G Post Operative Knee Brace CODE 723 CALF SUPPORT CODE 320 KNEE IMMOBILIZER CODE 884 KNEE SUPPORT 894 Neo G Hinged Open Knee Support (Kids Size Available) 888B Neo G Groin Support CODE 893 KNEE SUPPORT WITH FLEXIBLE STAYS CODE 163 TX KNEE BRACE WITH FLEXIBLE STAYS 898 Neo G Adjusta Fit Hinged Open Knee Support 320 Neo G Knee Immobilizer (S - XXL) (Kids Size Available) CODE 822 KNEE BRACE WITH PATELLA SUPPORT CODE 805 JUDO ANGORA KNEE BRACE 453 Neo G Airflow Plus Stabilized Knee Support (Sizes S - XL) CODE 803 ELASTIC KNEE BRACE CODE 456 KNITTED MALLEOL ANKLE SUPPORT 886 Neo G Patella Band 868 Hinged Stabilizing Knee Brace CODE 807 Judo Woolen Knee Support CODE 807 Neo G Wool Knee Warmer Code 755 ACTIVE KNEE SUPPORT (Neo G ) CODE 765 ACTIVE PLUS KNEE SUPPORT CODE 552 SILICONE METATARSAL PAD WITH SEPARATOR CODE 307 ELASTIC WRIST BRACE SPLINT 474 Neo G Plantar Fasciitis Everyday Support (Sizes S - XL) CODE 164 TX ANKLE BRACE WITH MALLEOL SUPPORTS CODE 549 SILICONE FOREFOOT INSOLE CODE 547 SILICONE RING CODE 827 ANKLE SUPPORT WITH SPIRAL STAYS CODE 165 TX WRIST BRACE SPLINT 854 Neo G Laced Ankle Brace (Sizes XS - L) CODE 865 REFLEX AFO CODE 825 WRIST BRACE SPLINT CODE 722 WRIST & THUMB SUPPORT CODE 545 SILICONE TOE SPREADER CODE 801 ELASTIC ANKLE BRACE 815 Neo G Ankle Brace with Sponge Pads CODE 554 SILICONE METATARSAL PAD WITH SEPARATOR 887-V Neo G Ankle Support CODE 871 SPORT SHORT CODE 550 SILICONE BUNION SHIELD CODE 864 AFO (Foot guard) CODE 590 ADHESIVE SILICONE LONGITUDINAL ARCH SUPPORT CODE 854 LACE ANKLE SUPPORT 816 Neo G Ankle Brace with Gel Pads 814 Neo G Ankle Brace with Air Pads CODE 724 ANKLE SUPPORT CODE 814 ANKLE STABILIZER (AIR PAD) CODE 474 PLANTAR FASCIITIS SUPPORT WITH SILICONE 865 Neo G Reflex AFO/Drop Foot (R/L) (Sizes S - XL) 164 Neo G RX Ankle Support (Sizes S - XL) CODE 888 THIGH SUPPORT CODE 824 ANKLE BRACE WITH BANDAGE CODE 455 KNITTED ACHILLES TENDON SUPPORT CODE 897 ANKLE BRACE WITH FLEXIBLE STAYS CODE 306 WRIST SPLINT WITH THUMB GRIP CODE 301 WRIST BRACE SPLINT 864 Neo G Anti-Rotation AFO Footguard (R/L) 887 Neo G Ankle Support with Figure of 8 Strap (Kids Size Available) CODE 582 ADHESIVE SILICONE MEDIAL & LATERAL WEDGE CODE 553 SILICONE TOE CREST WITH LOOP (RIGHT-LEFT) CODE 882 WRIST SUPPORT CODE 551 SILICONE METATARSAL PAD WITH RING CODE 887 ANKLE SUPPORT CODE 844 ANKLE BRACE WITH SUPPORT CODE 548 SILICONE TOE CAP CODE 589 ADHESIVE SILICONE METATARSAL PAD CODE 802 ELASTIC TENDON BRACE CODE 456 KNITTED MALLEOL ANKLE SUPPORT CODE 881 WRIST BAND 724 Neo G Airflow Ankle Support (Sizes S - XL) CODE 880 THUMB BRACE CODE 544 SILICONE HEEL SPUR CODE 815 ANKLE STABILIZER (SPONGE PAD) CODE 305 THUMB GRIP CODE 546 SILICONE TOE SEPARATOR CODE 542 SILICONE FULL LENGTH INSOLE 863 Neo G Drop Foot CODE 584 ADHESIVE SILICONE HEEL SPUR CODE 543 SILICONE 3/4 LENGTH INSOLE 456 Neo G Airflow Plus Ankle Support with Silicone (Sizes S - XL) CODE 816 ANKLE STABILIZER (GEL PAD) Code 754 ACTIVE ANKLE SUPPORT (Neo G) CODE 764 ACTIVE PLUS ANKLE SUPPORT 762 NEO G ACTIVE PLUS ACHILLES TENDON SUPPORT 139 Neo G Pregnancy Support Belt CODE 107 SANITARY PANTY CORSET CODE 130 ELASTIC DORSOLOMBER CORSET CODE 131 ELASTIC LUMBOSACRAL CORSET CODE 112 JUDO WAIST CORSET CODE 161 TX LUMBOSACRAL CORSET CODE 105 CORSET TYPE SKANDAL CODE 872 SPORT VEST CODE 109 PREGNANCY CORSET 135 Neo G Lumbostad Support/Brace 114 Neo G Waist/Back Warmer & Support (Sizes S - XL) CODE 145 ELASTIC LIGHT LUMBOSTAD CORSET CODE 114 JUDO ANGORA WAIST CORSET 185 Neo G Easy-Fit Back Brace CODE 139 ELASTIC PREGNANCY CORSET CODE 115 LUMBOSTAD CORSET CODE 181 SACRO-PLUS BACK BRACE PRO CODE 185 SACRO-PLUS BACK BRACE CODE 821 NEOPRENE LUMBOSTAD CORSET CODE 113 JUDO PANTY CORSET CODE 118 CLAVICLE BANDAGE CODE 162 TX DORSOLOMBER CORSET CODE 110 DORSOLOMBER CORSET CODE 890 PRACTICAL WAIST SUPPORT CODE 138 POSTUREX (CLAVICLE) CORSET CODE 884 KNEE SUPPORT 131 Neo G Lumbosacral Support/Brace 890 Neo G Back Brace with Power Straps CODE 137 RIB BELT CORSET 145 Neo G Light Lombostad Support/Brace CODE 101 HOOKED WAIST CORSET CODE 889 WAIST SUPPORT 161 Neo G RX Stabilized Back Brace (Sizes S - XL) CODE 140 ELASTIC DORSOLOMBER CORSET (HEIGHT ADJUSTABLE) 130 Neo G Dorsolumbar Support/Brace (Kids Size Available) CODE 135 ELASTIC LUMBOSTAD CORSET 891 Neo G Back Brace CODE 111 LUMBOSACRAL CORSET CODE 106 CORSET TYPE PANTY 889 Neo G Waist/Back Support CODE 117 Neo G Wool Waist Warmer CODE 115-C LUMBOSTAD CORSET WITH STEEL STAYS CODE 117 Judo Woolen Elastic Corset CODE 883 EPICONDYLITIS BANDAGE 892 Neo G Calf/Shin Splint Support CODE 760 EPICONDYLITIS BANDAGE 876 Neo G ITB Strap CODE 501 METAL FOOT SUPPORT CODE 723 CALF SUPPORT 896 Neo G Shoulder Support (R/L) 883 Neo G Tennis/Golf Elbow Strap CODE 892 CALF SUPPORT 160 Neo G RX Tennis/Golf Support CODE 888 THIGH SUPPORT 510 Neo G Bunion Correction System - Hallux Valgus Soft Support (R/L) 760 Neo G Tennis/Golf Elbow Clasp 511 Neo G Bunion Correction System - Hallux Valgus Night Splint (R/L) 723 Neo G Airflow Calf/Shin Support (Sizes S - XL) CODE 510 HALLUX VALGUS NIGHT SUPPORT CODE 511 HALLUX VALGUS NIGHT SPLINT 888 Neo G Thigh & Hamstring Support CODE 160 TX EPICONDYLITIS BANDAGE CODE 679 SEATING DONUT CUSHION D FORM CODE 661 VISCO ANATOMIC SEATING CUSHION CODE 660 VISCO SEATING DONUT CUSHION U FORM CODE 678 ANATOMIC BACK CUSHION (WITH BELT) CODE 677 BACK CUSHION (WITH BELT) CODE 659 VISCO SEATING DONUT CUSHION D FORM CODE 681 ANATOMIC SEATING CUSHION CODE 662 VISCO WHEELCHAIR SEATING CUSHION CODE 680 SEATING DONUT CUSHION U FORM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQF	Orthosis, Cervical-Thoracic, Rigid	Physical Medicine	Class 1	890.3490	2011-04-20
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	Class 1	890.3490	2013-08-15
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2011-04-20
IOZ	Splint, Abduction, Congenital Hip Dislocation	Physical Medicine	Class 1	890.3665	2011-04-20
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2013-07-09
IQJ	Splint, Clavicle	Physical Medicine	Class 1	890.3490	2013-08-15
NOJ	Prosthesis, Breast, External, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2011-04-20
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2011-04-20
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2013-06-24
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2011-04-20
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2011-04-20
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2011-04-20
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2013-06-24
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	2013-07-09

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Variteks Ortopedi Sanayi A.S.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

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Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009303371. Last updated year: 2026. Please use registration number 3009303371 when referencing this establishment in official correspondence.