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510(k) K964215 · HRX Arthroscope

ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM

Applicant	Smith & Nephew Endoscopy, Inc., Mansfield MA, US
Decision	Substantially Equivalent, Dec 20, 1996
Received	Oct 22, 1996
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K964215

Date	Firm and product	Code	Linked 510(k)
Oct 22, 2015	Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated	HWE	None listed
Oct 22, 2015	Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated	HWE	None listed
Oct 22, 2015	Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile Part Number: 7209236 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated	HWE	None listed
Oct 22, 2015	Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated	HWE	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.