United Orthopedic Corp.
United Orthopedic Corp. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2014, with 4 FDA device recalls on record.
Top product codes for United Orthopedic Corp.
FDA recalls by United Orthopedic Corp.
- Z-2885-2026 — Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
- Z-2883-2026 — Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
- Z-2884-2026 — Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
- Z-2886-2026 — Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by United Orthopedic Corp.
- K140073 — U2 FEMORAL COMPONENT, CR, CEMENTED
- K140075 — U2 FEMORAL COMPONENT, CR, POROUS COATED
- K132455 — U-MOTION II PS+ CUP
- K122185 — U-MOTION II ACETABULAR SYSTEM
- K122183 — AUGMENT AND SCREW, PSA TYPE
- K121777 — U2 ACETABULAR CUP, PLASMA SPRAY
- K111546 — U2 HIP SYSTEM
- K103497 — CERAMIC FEMORAL HEAD
- K101670 — UNITED U2 BIPOLAR IMPLANT
- K100981 — UNITED STEM, PSA TYPE
- K082424 — UNITED U2 TOTAL KNEE SYSTEM
- K082469 — UNITED U2 PATELLA
- K062978 — U2 HIP STEM, TI PLASMA SPRAY
- K051640 — U2 TOTAL KNEE SYSTEM
- K050269 — U1 HIP SYSTEM - BIPOLAR
- K050262 — U2 ACETABULAR COMPONENT
- K022520 — U2 ACETABULAR CUP
- K021657 — UKNEE TOTAL KNEE SYSTEM
- K003237 — U2 HIP STEM, TI POROUS COATED
- K994078 — U1 HIP SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.