FDA Registration
Active
🇺🇸 United States
POST OPERATIVE HIPO, M-L
Reg #: 2031918
·
FEI: 3002935344
·
Expires 2025
Products
1
Proprietary Names
205
Establishment Types
1
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2000-01-19 |
Proprietary Names
POST OPERATIVE HIPO, M-L
CAMP HIP, PELVIC ONLY, X-LARGE
Knee Joint, Pair, Short
REPLACE LINE FOR CAMP PEL ,XXL
REPLACEMENT LINER FOR UNIVERSAL HIP, THIGH, LARGE
REPL LINER FOR HIPO,T,M-R
Strap Low Profile Thigh 2 x 18
Leather Strap, Post Operative Hip Orthosis, Component #3, Left
UNFIN WAIST SOFT, LRG LEFT
POSTOP HIPO NO BLUE STRP MD-LT
NEOP UNIV HIP, COMPLETE, MED
PLASTIC PIECE FOR BACK OF WAIS
REPLACEMENT LINER FOR UNIVERSAL HIP, PELVIC, MEDIUM
NEOPRENE HIP JOINT COVER
#6 BAR - 2024T3 ALUMINUM, WITH HOLES, JR.
Liner, Neop. Univ Hip, W., Lg
UNFIN WAIST HARD, X-LRG LEFT
WAIST CAMP STYLE XTRA- XTRA LARGE LEFT
CAMP HIP, THIGH ONLY, LARGE
NEOP UNIV HIP, THIGH, MEDIUM
Knee Joint, Pair, With Condyle Pad Short
#2 BAR - 1/4" X 3/4", 2024T3 ALUMINUM, TWO SLOTS, STANDARD
Liner, LowProfile Waist, Large
Neoprene Strap POHO, Comp2 S-L
WAIST CAMP STYLE, SMALL- MEDIUM LEFT
LOW PRO HIPO,W,M-L
THIGHS CAMP STYLE SMALL
LOW PRO HIPO, (UNF), T, XL-L
LOW PRO HIPO, W, XL-R
LOW PRO HIPO, T, L-R
Aluminum Bar POHO 9 1/2" x 5/8" x 3/16"
Liner, LowProfile, Thigh Lg Rt
POST OPERATIVE HIPO, M-R
LOW PRO HIPO,W,S-L
LOW PRO HIPO, (UNF), T, L-L
NEOP UNIV HIP, THIGH, LARGE
Liner, LowProfile Waist, Small
CAMP HIP, PELVIC ONLY, XXL
NEOP UNIV HIP, PELVIC, X-LARGE
Knee Joint, Pair, Medium
CONDYLE PAD & COVER
REPLACE LINE FOR CAMP THIGH, S
REPLACEMENT LINER FOR UNIVERSAL HIP, THIGH, EXTRA LARGE
#3 BAR - 1/4" X 3/4", 2024T3 ALUMINUM, WITH TAPPED HOLES, CENTER HOLE & SLOTS - ABDUCTION
Liner, LowProfile Waist, Xt Lg
Neoprene Strap POHO, Comp2 S-R
Leather Strap, Post Operative Hip Orthosis, Component #3, Right
UNFIN WAIST SOFT, LRG RIGHT
WAIST CAMP STYLE SMALL- MEDIUM RIGHT
THIGHS CAMP STYLE MEDIUM
PIP Extnesion, Small
POST OPERATIVE HIPO, L-L
Liner, LowProfile, Thigh Md Rt
UNFINISHED PENDULOUS PANEL
LOW PRO HIPO,W,L-R
LOW PRO HIPO, T, M-R
CAMP HIP, THIGH ONLY, SMALL
NEOP UNIV HIP, PELVIC XX-LARGE
Knee Joint, Pair, Long
REPLACEMENT LINER FOR UNIVERSAL HIP, THIGH, EXTRA-EXTRA LARGE
NEOP UNIV HIP, PELVIC, LARGE
#1 BAR - 1/4" X 3/4", 2024T3 ALUMINUM, TWO SLOTS, TWO HOLES, FOR JOINT
Dacron Strap, Post Operative Hip Orthosis, Component #5, Universal
UNFIN WAIST SOFT, X-LRG LEFT
UNFINISHED THIGH SOFT XTRA LARGE LEFT
Liner, Neop. Univ Hip, T., Xlg
UNFINISHED THIGH SOFT LARGE LEFT
LOW PRO HIPO, T, S-L
LOW PRO HIPO (UNF), W, L-R
NEOP UNIV HIP, COMPLETE, XX-LG
POSTOP HIPO NO BLUE STRP LG-RT
REPLACEMENT LINER FOR UNIVERSAL HIP, PELVIC, EXTRA-EXTRA LARGE
LOW PRO HIPO, T, M-L
Extender Hook, Cadera 2" X 3"
Liner, Neop. Univ Hip, T., Sm
UNFINISHED THIGH SOFT, SMALL RIGHT
NEOP UNIV HIP, PELVIC, MEDIUM
CAMP HIP, PELVIC ONLY, SMALL
TIBURON'S ABDUCTION HINGE FOR POST OPERATIVE HIP ORTHOSIS
REPLACE LINE FOR CAMP PELVIC,M
REPL LINER FOR HIPO,T,S-L
Liner, Neop. Univ Hip, T., Lg
UNFINISHED THIGH SOFT MEDIUM RIGHT
UNFIN WAIST SOFT, SM RIGHT
LOW PRO HIPO (UNF), W, XL-L
POST OPERATIVE HIPO, S-L
LOW PRO HIPO, (UNF), T, M-L
POSTOP HIPO NO BLUE STRP SM-RT
LOW PRO HIPO,W,M-R
LOW PRO HIPO, (UNF), T, XL-R
LOW PRO HIPO (UNF), W, M-L
LOW PRO HIPO, (UNF), T, S-L
CAMP HIP, PELVIC ONLY, MEDIUM
NEOP UNIV HIP, THIGH, XX-LARGE
REPLACEMENT JOINT, ELBOW
REPLACE LINE FOR CAMP PELVIC,L
REPLACEMENT LINER FOR UNIVERSAL HIP, THIGH, SMALL
REPL LINER FOR HIPO,T,S-R
POSTOP HIPO NO BLUE STRP SM-LT
LOW PRO HIPO,W,S-R
LOW PRO HIPO, (UNF), T, L-R
LOW PRO HIPO,W,L-L
UNFIN WAIST SOFT, MED LEFT
Liner, LowProfile, Thigh Sm Rt
Neoprene Strap POHO, Comp2 M-R
THIGHS CAMP STYLE XTRA LARGE
POST OPERATIVE HIPO, L-R
LOW PRO HIPO, W, XL-L
LOW PRO HIPO, T, L-L
NEOP UNIV HIP, COMPLETE, SMALL
Condyle Pad, R2864 Black Foam
REPLACEMENT LINER FOR UNIVERSAL HIP, PELVIC, SMALL
LOW PRO HIPO, (UNF), T, S-R
STRAP FOR THIGH COMP MD/LG/XLG
LOW PRO HIPO (UNF), W, XL-R
REPL LINER FOR HIPO,W,M
#5 STAINLESS STEEL WITH CLEVIS FOR ALUMINUM BAR #1
Liner, Neop. Univ Hip, W., Med
UNFIN WAIST HARD, LRG RIGHT
WAIST CAMP STYLE LARGE-XTRA LARGE RIGHT
NEOP UNIV HIP, THIGH, X-LARGE
CAMP HIP, THIGH ONLY, MEDIUM
NEOP UNIV HIP, THIGH, SMALL
Condyle Pad, Lite Brace
REPL LINER FOR HIPO,T,L-L
CAMP HIP, THIGH ONLY, XX-LARGE
NEOP UNIV HIP, COMPLETE, X-LG
REPLACEMENT LINER FOR UNIVERSAL HIP, PELVIC, EXTRA LARGE
REPLACE LINE FOR CAMP THIGH, M
Knee Joint, Pair, With Condyle Pad Long
REPLACE STRAPS FOR CAMP HIP
STRAP FOR THIGH COMP., SMALL
Liner, Neop. Univ Hip, W., Sm
Liner, LowProfile, Thigh Sm Lt
Neoprene Strap POHO, Comp2 M-L
THIGHS CAMP STYLE LARGE
Liner, LowProfile, Thigh Lg Lt
#4 JOINT HEAD, CAST STAINLESS STEEL CENTER HOLE RECESSED, ABDUCTION
#1 BAR - 1/4" X 3/4", 2024T3 ALUMINUM, TWO SLOTS, W/JOINT HEAD
Strap Low Profile Thigh 2 x 24
Liner, LowProfile Thigh Xlg Lt
REPL LINER FOR HIPO,T,L-R
UNFIN WAIST HARD, LRG LEFT
WAIST CAMP STYLE LARGE- XTRA LARGE LEFT
Liner, LowProfile Waist, Med
Plastic belt, LDPE, Universal
UNFIN WAIST SOFT X-LRG RIGHT
UNFINISHED THIGH SOFT XTRA LARGE RIGHT
Strap Z Loop Cadera 2" X 24"
Liner, Neop. Univ Hip, W, 2Xlg
UNFINISHED THIGH SOFT, SMALL LEFT
Liner, Neop. Univ Hip, T, 2Xlg
LOW PRO HIPO (UNF), W, L-L
POSTOP HIPO NO BLUE STRP LG-LT
REPLACE LINE FOR CAMP THIGH,XL
UNFINISHED THIGH SOFT LARGE RIGHT
UNFIN WAIST HARD, SM LFT
LOW PRO HIPO (UNF), W, S-L
LOW PRO HIPO, T, XL-L
REPL LINER FOR HIPO,T,XL-R
UNFIN WAIST HARD, MED LEFT
POST OPERATIVE HIPO, S-R
CAMP HIP, THIGH ONLY, X-LARGE
LOW PRO HIPO, (UNF), T, M-R
TIBURON'S ABDUCTION HINGE FOR HIP ORTHOSIS
REPLACE LINE FOR CAMP PELVIC,S
REPL LINER FOR HIPO,W,XLG
Knee Joint, Pair, With Condyle Pad Medium
REPLACE LINE FOR CAMP THI ,XXL
STRAP FOR WAIST COMP., UNIV
REPLACE LINE FOR CAMP THIGH, L
REPL LINER FOR HIPO,T,XL-L
UNFIN WAIST HARD, MED RIGHT
UNFIN WAIST HARD, SM RIGHT
CAMP HIP, PELVIC ONLY, LARGE
LOW PRO HIPO (UNF), W, S-R
LOW PRO HIPO, T, XL-R
JOINT, PLASTIC BLACK KYDEX
REPLACE LINE FOR CAMP PEL , XL
REPLACEMENT LINER FOR UNIVERSAL HIP, THIGH, MEDIUM
REPL LINER FOR HIPO,T,M-L
UNFIN WAIST SOFT, SM LEFT
LOW PRO HIPO (UNF), W, M-R
Strap LowProfile Pelvic 2 x 24
Liner, LowProfile Thigh Xlg Rt
UNFIN WAIST SOFT, MED RIGHT
LOW PRO HIPO, T, S-R
Liner, LowProfile, Thigh Md Lt
Neoprene Strap POHO, Comp2 L-L
THIGHS CAMP STYLE XTRA-XTRA LARGE
NEOP UNIV HIP, PELVIC, SMALL
RPLMT LINER FOR HIPO, W SMALL
Aluminum Bar HIP 3 3/4" x 1/4 x 3/4"
RPLMT LINER FOR HIPO, W - LG
Liner, Neop. Univ Hip, T., Med
UNFINISHED THIGH SOFT MEDIUM LEFT
POSTOP HIPO NO BLUE STRP MD-RT
NEOP UNIV HIP, COMPLETE, LARGE
REPLACEMENT LINER FOR UNIVERSAL HIP, PELVIC, LARGE
#7 ALUMINUM BAR WITH TAPPED HOLES, JR.
Strap Z Loop Cadera 2" X 18"
Liner, Neop. Univ Hip, W., Xlg
Neoprene Strap POHO, Comp2 L-R
UNFIN WAIST HARD, X-LRG RIGHT
WAIST CAMP STYLE XTRA-XTRA LARGE RIGHT
Establishment Types
Manufacture Medical Device