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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: 135 mm Reusable Slat, SE Retr, 10 Pack; 155 mm Reusable Slat, SE Retr, 10 Pack; 175mm Reusable Slat, SE Retr, 10 Pack; 90 mm Reusable Slat, SE Retr, 10 Pack; AEQUALIS RESURFACING HEAD; AEQUALIS REVERSED; Aequalis" Instrument; Aequalis" Retractor Shoulder System; Eiberg Retractor, Standard; Eiberg Retractor, Standard, Long; Eikon LT Adapt SE 135 mm, Wide Retractor; Eikon LT Adapt SE 135mm Retractor; Eikon LT Adapt SE 135mm, Teeth Retractor; Eikon LT Adapt SE 155 mm, Wide Retractor; Eikon LT Adapt SE 155 mm,Wide,Teeth Retr; Eikon LT Adapt SE 155mm Retractor; Eikon LT Adapt SE 155mm, Teeth Retractor; Eikon LT Adapt SE 175 mm, Wide Retractor; Eikon LT Adapt SE 175 mm,Wide,Teeth Retr; Eikon LT Adapt SE 175mm Retractor; Eikon LT Adapt SE 175mm, Teeth Retractor; Eikon LT Adapt SE 90 mm, Wide Retractor; Eikon LT Adapt SE 90 mm, Wide Teeth Retr; Eikon LT Adapt SE 90mm Retractor; Eikon LT Adapt SE 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide, Teeth Retractor; Eikon LT Adapt, 135 mm; Eikon LT Adapt, 135 mm, Teeth; Eikon LT Adapt, 135 mm, Wide; Eikon LT Adapt, 135 mm, Wide, Teeth; Eikon LT Adapt, 175 mm; Eikon LT Adapt, 175 mm, Teeth; Eikon LT Adapt, 90 mm; Eikon LT Adapt, 90 mm, Teeth; Eikon LT Adapt, 90 mm, Wide; Eikon LT Adapt, 90 mm, Wide, Teeth; Eikon LT FF 135mm Retractor; Eikon LT FF 135mm, Wide Retractor; Eikon LT FF 175mm Retractor; Eikon LT FF 90mm Retractor; Eikon LT FF 90mm, Wide Retractor; Eikon LT FF Replacement Screw; Eikon LT Fixed Frame Retractor, 135mm Eval; Eikon LT Fixed Frame Retractor, 135mm Wide Eval; Eikon LT Fixed Frame Retractor, 90mm Eval; Eikon LT Fixed Frame Retractor, 90mm Wide Eval; Eikon LT Retractor, 135 mm; Eikon LT Retractor, 135 mm, Narrow; Eikon LT Retractor, 135 mm, Narrow Teeth; Eikon LT Retractor, 135 mm, Sweetheart; Eikon LT Retractor, 135 mm, Teeth; Eikon LT Retractor, 135 mm, Wide; Eikon LT Retractor, 135 mm, Wide, Teeth; Eikon LT Retractor, 175 mm; Eikon LT Retractor, 175 mm, Teeth; Eikon LT Retractor, 40 mm, Extra Narrow; Eikon LT Retractor, 40 mm, Narrow; Eikon LT Retractor, 50 mm; Eikon LT Retractor, 50 mm, Teeth; Eikon LT Retractor, 90 mm; Eikon LT Retractor, 90 mm, Narrow; Eikon LT Retractor, 90 mm, Narrow Teeth; Eikon LT Retractor, 90 mm, Teeth; Eikon LT Retractor, 90 mm, Wide; Eikon LT Retractor, 90 mm, Wide, Teeth; Eikon LT Retractor, A-N, 35 mm & 50 mm; Eikon LT Retractor, Rich, 40mm x 38mm; Eikon LT Retractor, Rich, 60mm x 45mm; Eikon LT Retractor, Rich, 80mm x 60mm; Glenoid Retractor; HLS NOETOS; HLS UNI EVOLUTION; Invuity A-N, 35mm & 50mm Extra Narrow Re; Invuity A-N, 35mm & 50mm Extra Narrow Retractor; Invuity A-N, 35mm & 50mm Narrow Retracto; Invuity A-N, 35mm & 50mm Narrow Retractor; Invuity Breisky 130mm; Invuity Breisky 170mm; Invuity Deaver 25mm Wide Retractor; Invuity Deaver 38mm Wide Retractor; Invuity St. Marks 11 in Retractor; Invuity St. Marks 9 in Retractor; Retractor; Reusable Slat for Eikon LT Adapt Smoke Evacuation 135 mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 155mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 175mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 90mm Retractor, 10 Pack; St. Mark’s 11 in. Retractor; St. Mark’s 9 in. Retractor; Tornier Approach
Classification Name: RETRACTOR
Product Code: GAD
Device Class: 1
Regulation Number: 878.4800
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: STRYKER SPINE
Registered Establishment Number: 9617544
Owner/Operator: STRYKER CORP.
Owner/Operator Number: 1811755
Establishment Operations: Contract Manufacturer
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