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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 0 HI 95mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 0 STD 95mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 1 HI 97mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 1 STD 97mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 10 HI 115mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 10 STD 115mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 11 HI 117mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 11 STD 117mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 12 HI 119mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 12 STD 119mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 2 HI 99mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 2 STD 99mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 3 HI 101mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 3 STD 101mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 4 HI 103mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 4 STD 103mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 5 HI 105mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 5 STD 105mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 6 HI 107mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 6 STD 107mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 7 HI 109mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 7 STD 109mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 8 HI 111mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 8 STD 111mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 9 HI 113mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® BPS W/GRIPTION? SIZE 9 STD 113mm; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 10mm LAT; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 10mm STD; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 11.3mm LAT; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 11.3mm STD; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 12.5mm LAT; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 12.5mm STD; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 13.8mm LAT; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 13.8mm STD; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 15mm LAT; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 15mm STD; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 17.5mm LAT; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 17.5mm STD; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 6.3mm STD; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 7.5mm LAT; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 7.5mm STD; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 8.8mm LAT; FEMORAL STEM 12/14 TAPER TRI-LOCK® Ti W / POROCOAT® SIZE 8.8mm STD
Classification Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED
Product Code: LZO
Device Class: 2
Regulation Number: 888.3353
Medical Specialty: Orthopedic
Registered Establishment Name: Sterigenics US, LLC
Registered Establishment Number: 1526534
Owner/Operator: Sterigenics International, LLC
Owner/Operator Number: 10029425
Establishment Operations: Contract Sterilizer
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