FDA Registration Active 🇺🇸 United States

DYNAMIC ELBOW FLEXION SPLINT KIT

Reg #: 2031918 · FEI: 3002935344 · Expires 2025
Products
1
Proprietary Names
453
Establishment Types
2
Classifications
1

Registration Details

Registration Name
TIBURON MEDICAL ENTERPRISES
Registration Number
2031918
FEI Number
3002935344
Status
Active
Expiry Year
2025
Initial Importer
No
Address
915 INDUSTRIAL WAY
City
SAN JACINTO
State
CA
ZIP
92582
Country
US

Owner / Operator

Firm Name
TIBURON MEDICAL ENTERPRISES
Operator Number
9040187
Address
915 INDUSTRIAL WAY, --
City
San Jacinto
State
CA
Postal Code
92582
Country
US

Products

Device Name Product Code
Orthosis, Limb Brace IQI

Proprietary Names

DYNAMIC ELBOW FLEXION SPLINT KIT UNIV SHOULDER IMMOBILIZER, MEDIUM APL ELBOW BRACE, RIGHT Knee Back Stop, Small MOTION ELBOW RANGER LINER-SM CalfSleeveBlackTC1601 NYL XXLg Calf BlckTC1601 POL BX M X-Lg ElbowSleeveFlgRedTC1701 NYL Md ElbowSleeveBlackTC1701 POL Lg ElbowSleeveGrayTC1701 POL Med ElbwSlevNUDE TC0503 POL 2X-lg ElbowGrey 0503 POL BX M X-Lg Immobilizador Pierna de Terry, Medium STANDARD HFB SLEEVE, L CalfSleveSilverTC1601 NYL Sm CalfSleeveNudeTC0203 POL XLg CalfSlvBlckTC1601 POL BX W Med ElbowSleevePLUMTC0503 NYL XLg ElbowSleeveBlueTC1701 POL Med ElbowBlueTC1701 POL BX M Lg ElbowBlueTC1701 POL BX W Sm ElbowPlumTC1701 POL BX W 2X-Lg Brazo O&P With Foam, Large Right UNIVERSAL DELUXE SHOULDER IMMOBILIZER 15 DEGREE, MEDIUM OTS EXT2 HUM SLEEVE, LARGE ULNAR FRACTURE BRACE KIT, SMALL REPLACEMENT STRAPS, MOTION ELBOW RANGER, SMALL CalfSleeveGrayTC1601 NYL Lg CalfSleveWhiteTC1601 NYL XXLg CalfSleeveBlackTC1601 POL XXLg CalfSlvNudeTC1601 POL BX M Lg ElbowSleeveBlackTC1701 NYL Med ElbowSleveGrayTC1701 POL XXXLg ElbowNudeTC1701 POL BX M X-Lg Banda Neoprene, Large ELBOW EXTENSION SPLINT, MEDIUM OTS EXT2 HFB KIT, X-LARGE ULNAR FRACTURE BRACE SLEEVE,L Straps & Pads, AK Brace, Child Static Pediatric Elbow, Small EXTENDED HFB KIT,SMALL CalfSleeveBlueTC1601 NYL XXXL CalfSlvWHT TC1601 NYL BX W Lg CalfSleeveGrayTC1601 POL XXXLg Calf SleeveBlueTC1601 POL Md ElbowSleveWhtTC1701 NYL XXXLg ElbowWhitTC1701 NYL BX M X-Lg ElbowSleeveflgRedTC1701 POL Lg ROMEO - Elbow Orhtosis, Small AK Training Brace, Child UNIVERSAL DELUXE SHOULDER IMMOBILIZER 15 DEGREE, LARGE OTS EXT2 HUM SLEEVE, X-LARGE ULNAR FRACTURE BRACE KIT, M UNIV SHOULDER IMMOBLZR, LARGE OTS EXT2 HUM SLEEVE, X-SMALL Static Prog. Elbow Exension Sm CalfSleeveNudeTC0203 NYL XX-Lg CalfSleveSilverTC1601 POL XXLg ElbowSleeveGrayTC1701 NYL Lg ElbowSlevePINKTC1701 POL XXXLg ElbowSleevePLUMTC0503 POL Med ElbowNudeTC1701 POL BX W Lg Tongue, Short Humeral, Medium Child Short Leg Walker, Small Liner, Universal Shoulder Immobilizer, Large STANDARD HFB KIT, EXTRA LARGE OTS EXT2 HFB KIT, MEDIUM ULNAR FRACTURE BRACE SLEEVE,S Knee Back Stop, Medium SPR Turnbuckle Elbow, Small REPLACEMENT STRAPS, MOTION ELBOW RANGER, MEDIUM CalfSleveGrayTC1601 NYL XLg CalfSleveWhteTC1601 NYL XXXL CalfSleveBlackTC1601 POL XXXLg MOTION ELBOW RANGER LINER-MED ElbowSleeveBlackTC1701 NYL Lg ElbowSleeveWhiteTC1701 POL Sm ElbowNudeTC1701 POL BX M 2X-Lg Component AK Thigh Cuff, Adult CalfSleveBlackTC1601 NYL XXXLg Banda Neoprene, Small Calf BlckTC1601 POL BX M 2X-Lg CalfSlvNudeTC1601 POL BX W XL ElbowSleeveflgRedTC1701 NYL Lg ElbowSleeveBlackTC1701 POL XLg ElbowSleeveGrayTC1701 POL Lg ElbowNudeTC1701 POL BX M Sm Immobilizador Pierna de Terry, Large Outter Sole w/Straps for Shoe Lift, Adult STATIC PROGRESSIVE SERRATED HINGE KIT, ELBOW CalfSleeveBlueTC1601 NYL XLg CalfSlvWHT TC1601 NYL BX W Sm CalfSleeveGrayTC1601 POL XLg ElbowSleeveBlueTC1701 NYL Med ElbowSleeveWhiteTC1701 NYL XLg ElbowWhitTC1701 NYL BX M Med ElbowSleveWhiteTC1701 POL XXLg ElbowSleeveFlgRedTC1701 POL Sm UNIVERSAL SHOULDER IMMOBILIZER, EXTRA LARGE OTS EXT2 HUM SLEEVE, SMALL EXTENDED HFB SLEEVE, XL STANDARD HFB KIT, XL SPR Turnbuckle Elbow, Medium MOTION ELBOW RANGER LINER-LG Calf Sleeve Gray TC1601 NYL Sm CalfSleveWhiteTC1601 NYL Lg CalfSlvNudeTC1601 POL BX M Sm CalfSlvNudeTC1601 POL BX W 2X ElbowSleveBlackTC1701 POL XXLg ElbowSleeveGrayTC1701 POL XLg ElbowNudeTC1701 POL BX M Med Immobilizador Pierna de Terry, Extra Large CalfSleeveWhiteTC1601 NYL Sm CalfSleeveNudeTC0203 NYL Lg CalfSleeveSilverTC1601 POL Lg CalfSlvNudeTC1601 POL BX W LG ElbowSleeveGrayTC1701 NYL Sm ElbowSleevePINKTC1701 POL XLg ElbowNudeTC1701 POL BX W Sm EXTENDED HFB SLEEVE, S STANDARD HFB KIT, S TURNBUCKLE ELBOW - L Child Dorsi Stretch AFO, Large Unf Kidex Forearm, HipSo Brace Motion Elbow Ranger with Sling, Medium EXTENDED HFB SLEEVE, L STANDARD HFB KIT, L CalfSleveSilverTC1601 NYL XLg Calf BlckTC1601 POL BX W 2X-Lg ElbowSleeveBlueTC1701 NYL XLg ElbowWhitTC1701 NYL BX M Sm ElbowSleeveBlueTC1701 POL XXLg ElbowSleevePINKTC1701 POL Sm ElbowBlueTC1701 POL BX W X-Lg EXT 2 HUMERAL STRAPS REPLACEMENT HUMERAL SOCK - PAIR CalfSleveSilvrTC1601 NYL XXXL Replacement Foam pads for Shoe Build-Up, Adult CalfSleeveNudeTC0203 NYL Med CalfSlvNudeTC1601 POL BX W MD ElbowSleveBlueTC1701 NYL XXXLg ElbowSleeveGrayTC1701 POL Sm ElbowSleevePINKTC1701 POL Lg ElbowPlumTC1701 POL BX W Sm Strap Extended Hummeral 1" x 23.5" Immobilizador Pierna de Terry, Small Calf Sleeve BlackTC1601 NYL Md CalfSleveWhiteTC1601 POL XXLg CalfSlvBlckTC1601 POL BX M Sm ElbowSleveSilverTC1701 NYL XXL ElbowWhitTC1701 NYL BX W 2X-Lg ElbwSlevNUDE TC0503 POL Med ElbowGrey 0503 POL BX M Sm Liner, Deluxe Shoulder Immobilizer, Extra Large Repl Liner&Strap Kit, HipSo Sh Motion Elbow Ranger with Sling, Large REPL. PADS, ELBOW TRNBKL, SM ELBOW EXTENSION SPLINT, LARGE External Rotation Wedge for Deluxe 15 degree Shoulder Immobilizer STANDARD HFB KIT, MEDIUM OTS EXT2 HFB KIT, X-SMALL ULNAR FRACTURE BRACE KIT, L STANDARD HFB SLEEVE, M Static Pediatric Elbow, Extra Large O&P ELBOW BRACE, SM-LT EXTENDED HFB KIT, X-LARGE Motion Elbow Ranger, Medium ELBOW EXTENSION SPLINT, SMALL Repl Top-Bot Pads Strps Chld Short Leg Training Brace Adult STANDARD HFB SLEEVE, S Adv Dyn Elbow Ext Orth. Large Calf Sleeve BlackTC1601 NYL Lg CalfSleveWhiteTC1601 POL XXXLg CalfSlvBlckTC1601 POL BX M Med ElbwSleveSilvTC1701 NYL XXXLg ElbowSleeveBlackTC1701 POL Sm ElbwSlevNUDE TC0503 POL Lg ElbowGrey 0503 POL BX M Med DYNAMIC ATTACHMENT FOR PROGRESS ELBOW HINGE SPLINT, KIT Child Short Leg Walker, Large STANDARD HUMERAL FRACTURE BRACE KIT, EXTRA SMALL OTS EXT2 HFB KIT, LARGE ULNAR FRACTURE BRACE SLEEVE,M Calf SleeveBlueTC1601 NYL Md CalfSleeveGrayTC1601 POL Med ElbowSleveBlackTC1701 NYL XXLg ElbowSleeveWhiteTC1701 NYL Med ElbowSleeveWhiteTC1701 POL Lg Liner, External Rotation Wedge Pillow for Deluxe Shoulder Immobilizer 15d ElbowSleveSilverTC1701 POL XXL O&P ELBOW BRACE, SM-RT Static Prog. Elbow Exension Md Alum. Comp Knee Back Stp, Med Diamomnd Knurl Screw .50" Shoe Lift, Child UNIVERSAL DELUXE SHOULDER IMMOBILIZER 15 DEGREE, SMALL Static Pediatric Elbow, Extra Small EXTENDED HFB KIT, X-SMALL UNIVERSAL DELUXE SHOULDER IMMOBILIZER 15 DEGREE, EXTRA LARGE STANDARD HFB KIT, SMALL ULNAR FRACTURE BRACE KIT, MEDIUM Replacement Liner, Child Short Leg Walker, Large O&P ELBOW BRACE, MD-RT Adv Dyn Elbow Ext Orth. Small OTS EXT2 HUM SLEEVE, MEDIUM CalfSlevGryTC1601 NYL XXXLg CalfSleeveNudeTC0203 POL Lg CalfSlvBlckTC1601 POL BX W Sm ElbowSleevePLUMTC0503 NYL Lg ElbowWhitTC1701 NYL BX W Sm ElbowSleeveBlueTC1701 POL Sm EXTENDED HFB SLEEVE, X-SMALL ElbowBlueTC1701 POL BX M Med TURNBUCKLE ELBOW - M ElbowBlckTC1701 POL BX W 2X-Lg ElbowPlumTC1701 POL BX W X-Lg Brazo O&P With Foam, Large Left CalfSlvWHT TC1601 NYL BX M Md CalfSleeveWhiteTC1601 POL Md ElbowSleveGrayTC1701 NYL XXXLg ElbowSleveSilverTC1701 NYL Med ElbowWhitTC1701 NYL BX W Med ElbowSleeveSilverTC1701 POL Lg ElbowSleevePLUMTC0503 POL XXLg Straps & Pads, AK Brace, Adult Liner, Deluxe Shoulder Immobilizer, Small KNURLED SCREWS, THIGH SECT AK SPR Turnbuckle Elbow, Large Component BK Calf Cuffs, Child Knee Back Stop, Large O&P ELBOW BRACE, MD-LT Static Prog. Elbow Exension Lg REPLACEMENT TURNBUCKLE, XS Replacement Liner, Child Dorsi Stretch AFO, Small CalfSleeveBlueTC1601 NYL XXLg CalfSlvWHT TC1601 NYL BX W Md CalfSleeveGrayTC1601 POL XXLg Calf SleeveBlueTC1601 POL Sm ElbowSleeveBlueTC1701 NYL Lg ElbowSleveWhiteTC1701 NYL XXLg ElbowWhitTC1701 NYL BX M Lg ElbowSleeveFlgRedTC1701 POL Md Liner, Sammons Turnbuckle Elbow, Large REPLACEMENT STRAPS, MOTION ELBOW RANGER, LARGE Calf SleeveBlueTC1601 NYL Sm CalfSleeveGrayTC1601 POL Sm ElbowSleeveBlackTC1701 NYL XLg ElbowSleeveWhiteTC1701 POL Med ElbowSleveSilverTC1701 POL XLg ElbowBlackTC1701 POL BX W X-Lg CalfSlvWHT TC1601 NYL BX W Xl CalfSleveSilverTC1601 POL Sm Calf SleeveBlueTC1601 POL Lg ElbowSleevePINKTC1701 NYL Sm ElbowWhitTC1701 NYL BX M 2X-Lg ElbwSleeveFlgRedTC1701 POL XL ElbowBlackTC1701 POL BX M Sm MOTION ELBOW SLING CalfSlevGrayTC1601 NYL XXLg Calf SleeveBlackTC1601 POL XLg CalfSleeveNudeTC0203 POL Med CalfSlvNudeTC1601 POL BX M 2X Strap set, Ulnar Brace. Calf Sleeve Gray TC1601 NYL Md CalfSlevewhiteTC1601 NYL XLg ElbowSleevePLUMTC0503 NYL Med Alum. Comp Knee Back Stp, Sm ElbwBlckTC1701 POL BX W 2X- Lg ElbowSleveBlackTC0503 POL 6XLg CalfSlvNudeTC1601 POL BX M Md ElbowBlueTC1701 POL BX M Sm ElbowSleeveBlackTC1701 NYL Sm ElbowPlumTC1701 POL BX W Lg ElbowSleveBlackTC0503 POL 3XLg ElbowSleeveGrayTC1701 POL XXLg ElbowNudeTC1701 POL BX M Lg TURNBUCKLE ELBOW LINER, SMALL Brazo O&P With Foam, Medium Right CalfSlvWHT TC1601 NYL BX W 2X CalfSleeveSilverTC1601 POL Md Immobilizador Pierna de Terry, 2xtra Large CalfSleeveBlueTC1601 POL XLg ElbowSleevePINKTC1701 NYL Med ElbwSleeveFlgRedTC1701 NYL XL ElbowBlackTC1701 POL BX W Sm ElbwSleveFlRedTC1701 POL XXLg ElbowBlackTC1701 POL BX M Med CalfSleeveSilverTC1601 NYL Lg Calf BlckTC1601 POL BX W X-Lg KNURLED SCREWS, CALF SECT BK Replacement Strap Kit, KBS Med ElbowSlevePLUMTC0503 NYL XXXLg CalfSleeveWhiteTC1601 NYL Md ElbowSleeveBlueTC1701 POL XLg CalfSleeveNudeTC0203 NYL XLg ElbowSleveWhtTC1701 POL XXXLg CalfSleveSilverTC1601 POL XLg ElbowBlueTC1701 POL BX M 2X-Lg ElbowSleeveGrayTC1701 NYL Med ElbowBlueTC1701 POL BX W Lg ElbowSleevePINKTC1701 POL XXLg ElbowNudeTC1701 POL BX W Med Standard Humeral Fracture Brace Sleeve, Extra Small O&P ELBOW BRACE, LG-LT Adv Dyn Elbow Ext Orth. Medium Liner for Universal Abduction Pillow Tongue, Short Humeral, Small Child Dorsi Stretch AFO, Medium Unfinished Hip for HipSo Brace Motion Elbow Ranger with Sling, Small Liner, Sammons Turnbuckle Elbow, Small REPLACEMENT TURNBUCKLE, M Replacement Liner, Child Dorsi Stretch AFO, Large Static Pediatric Elbow, Medium EXTENDED HFB KIT, MEDIUM O&P ELBOW BRACE, LG-RT ULNAR FRACTURE BRACE KIT, S TURNBUCKLE ELBOW LINER, LARGE Calf Sleeve BlackTC1601 POL Md CalfSleeveBlueTC1601 POL XXXL ElbowSleevePINKTC1701 NYL XLg ElbwSleveFRedTC1701 NYL XXXLg ElbowBlackTC1701 POL BX W Lg ElbowSleveBlackTC0503 POL 4XLg ElbwSlevPLMTC0503 POL Sm ElbowBlackTC1701 POL BX M X-Lg ElbowNudeTC1701 POL BX W 2X-Lg Liner, Universal Shoulder Immobilizer, Medium Brazo O&P With Foam, Small Right UNIV SHOULDER IMMOBLZR, SMALL Component BK Calf Cuffs, Adult Replacement Strap Kit, KBS Sm APL ELBOW BRACE, LEFT REPL. PADS, ELBOW TRNBKL MD/LG Replacement Foam pads for Shoe Build-Up, Child Ankle Joint Comp Trn Brce Chld Replacement Strap Kit, KBS Lg Rnd Black Ball W/Hook Attached STANDARD HFB KIT, LARGE OTS EXT2 HFB KIT, SMALL ULNAR FRACTURE BRACE KIT, LARGE Liner, Sammons Turnbuckle Elbow, Medium REPLACEMENT TURNBUCKLE, L ROMEO - Elbow Orhtosis, Medium TURNBUCKLE ELBOW STRAP KIT REPLACEMENT TURNBUCKLE, S Replacement Liner, Child Dorsi Stretch AFO, Medium Calf Sleeve BlackTC1601 POL Lg TURNBUCKLE ELBOW LINER, MEDIUM Calf SleeveNudeTC0203 POL Sm CalfSlvNudeTC1601 POL BX M Xl ElbowSleevePINKTC1701 NYL XXLg ElbwSlevPLMTC0503 NYL Sm ElbowBlckTC1701 POL BX W X- Lg ElbowSleveBlackTC0503 POL 5XLg ElbowBlckTC1701 POL BX M 2X-Lg ElbowPlumTC1701 POL BX W Med AK Training Brace, Adult Ankle Joint Comp Trn Brce Adlt Brazo O&P With Foam, Medium Left Calf Sleeve BlackTC1601 POL Sm CalfSleeveBlueTC1601 POL XXLg ElbowSleevePINKTC1701 NYL Lg ElbwSleveFlRedTC1701 NYL XXLg ElbowBlackTC1701 POL BX W Med ElbwSleveFRedTC1701 POL XXXLg ElbowBlackTC1701 POL BX M Lg ElbowNudeTC1701 POL BX W X-Lg Liner, Universal Shoulder Immobilizer, Small Brazo O&P With Foam, Small Left Component AK Thigh Cuff, Child Repl Top-Bot Pads Strps Adlt CalfSleveNudeTC0203 NYL XXX-Lg CalfSleveSilvrTC1601 POL XXXL ElbowSleeveGrayTC1701 NYL XLg ElbowSlevePINKTC1701 NYL XXXLg ElbowSleeveSilverTC1701 POL Sm ElbowSleevePLUMTC0503 POL Lg Tongue, Short Humeral, Large Liner, Universal Shoulder Immobilizer, Extra Large Static Pediatric Elbow, Large EXTENDED HFB KIT, LARGE Motion Elbow Ranger, Small Calf Sleeve BlackTC1601 NYL Sm CalfSlvWHT TC1601 NYL BX M Xl CalfSleveWhiteTC1601 POL XLg CalfSleveNudeTC0203 POL XXX-Lg ElbowSleveSilverTC1701 NYL XLg ElbowWhitTC1701 NYL BX W X-Lg ElbwSlevNUDE TC0503 POL Sml Liner, Deluxe Shoulder Immobilizer, Large Child Dorsi Stretch AFO, Small HipSo Shoulder Brace, Univ. HUMERAL SLING Motion Elbow Ranger, Large Calf SleeveBlueTC1601 NYL Lg CalfSlvWHT TC1601 NYL BX M 2X CalfSleeveGrayTC1601 POL Lg ElbowSleeveBlueTC1701 NYL Sm ElbowSleeveWhiteTC1701 NYL Lg ElbowSleeveWhiteTC1701 POL XLg ElbwSleveSilvTC1701 POL XXXLg Calf SleeveBlackTC1601 NYL XLg CalfSlvBlckTC1601 POL BX M Lg ElbowSleeveFlgRedTC1701 NYL Sm ElbowSleeveBlackTC1701 POL Med ElbwSlevNUDE TC0503 POL X-lg ElbowGrey 0503 POL BX M Lg PLASTIC ELBOW HINGE EXTENDED HFB SLEEVE, M STANDARD HFB KIT, M Alum. Comp Knee Back Stp, Lg ROMEO - Elbow Orhtosis, Large Diamomnd Knurl Screw .437" Screws & Wrench For Stirrups Replacement Liner, Child Short Leg Walker, Small Short Leg Training Brace Child Shoe Lift, Adult CalfSlvWHT TC1601 NYL BX M Sm CalfSleeveWhiteTC1601 POL Sm ElbowSleeveGrayTC1701 NYL XXLg ElbowSleeveSilverTC1701 NYL Sm ElbowSleveSilverTC1701 POL Med ElbowSleevePLUMTC0503 POL XLg Tongue, Extended Humeral, Universal Sock, Humeral #2 (Calcetin), Pair Outter Sole w/Straps for Shoe Lift Child CalfSleveSilverTC1601 NYL XXLg Calf SleeveNudeTC0203 NYL Sm CalfSlvNudeTC1601 POL BX W Sm ElbowSleeveBlueTC1701 NYL XXLg ElbowSleveBlueTC1701 POL XXXLg ElbowSleevePINKTC1701 POL Med ElbowBlueTC1701 POL BX W 2X-Lg Strap Extended Hummeral 1" x 55.5" Repl Straps, Child Walker CalfSlvWHT TC1601 NYL BX M Lg CalfSleveWhiteTC1601 POL Lg CalfSleeveNudeTC0203 POL XX-Lg ElbowSleeveWhiteTC1701 NYL Sm ElbowSleeveSilverTC1701 NYL Lg ElbowWhitTC1701 NYL BX W Lg ElbowSlevePLUMTC0503 POL XXXLg Liner, Deluxe Shoulder Immobilizer, Medium STANDARD HFB SLEEVE, XL TURNBUCKLE ELBOW - S CalfSleeveSilverTC1601 NYL Md CalfSlvBlckTC1601 POL BX W Lg ElbowSleevePLUMTC0503 NYL XXLg ElbowSleeveBlueTC1701 POL Lg ElbowBlueTC1701 POL BX M X-Lg ElbowBlueTC1701 POL BX W Med

Establishment Types

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