ClearanceBrief
Panels › Orthopedic › Product code MAI · Class 2

Fastener, Fixation, Biodegradable, Soft Tissue

Regulation 888.3030

5510(k)s in 12 months (221 all time)
9recalls in 12 months (97 all time)
96recalls that name a 510(k)
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Top companies in MAI

Company510(k)sRecalls
Arthrex, Inc.467
Smith & Nephew, Inc.1043
Depuy Mitek, A Johnson & Johnson Company1825
Aju Pharm Co., Ltd.58
Smith & Nephew Inc., Endoscopy Division112
Bionx Implants, Inc.110
Linvatec Corp.110
Medos International SARL80
Conmed Corporation51
Acuitive Technologies50
Decided510(k)Device and applicantCode
Jan 6, 1998K973849BIOABSORBABLE BANKART TACK
Hogan & Hartson
MAI
Nov 10, 1997K965228FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
United States Surgical, A Division of Tyco Healthc
MAI
Nov 3, 1997K973281THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*
United States Surgical, A Division of Tyco Healthc
MAI
Jul 9, 1997K971358BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
Arthrex, Inc.
MAI
Jun 9, 1997K970896MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
ETHICON, Inc.
MAI
Jun 9, 1997K964805BIO-ANCHOR
Linvatec Corp.
MAI
May 22, 1997K963369BIO-ANCHOR
Linvatec Corp.
MAI
May 6, 1997K963396BIOSPHERE SUTURE ANCHOR
Instrument Makar, Inc.
MAI
Feb 24, 1997K964013MITEK ABSORBABLE TOGGLE ANCHOR
Mitek Products
MAI
Feb 6, 1997K964521DEPUY DUPONT PHANTOM SUTURE ANCHOR
Depuy, Inc.
MAI
Aug 1, 1996K961789RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
Zimmer, Inc.
MAI
Jul 9, 1996K960555BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
Instrument Makar, Inc.
MAI
Mar 4, 1996K955768BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM
Bioscience, Inc.
MAI
Feb 29, 1996K955486BIO-ANCHOR
Linvatec Corp.
MAI
Feb 6, 1996K952687PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM
ETHICON, Inc.
MAI
Jan 31, 1996K955003BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK
Bioscience, Inc.
MAI
Jan 26, 1996K944544ABSORBABLE BONE SCREW
Johnson & Johnson Professionals, Inc.
MAI
Nov 7, 1995K950275RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
Zimmer, Inc.
MAI
Aug 7, 1995K952471BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD
Bioscience, Inc.
MAI
Jul 31, 1995K943249BIOABSORBABLE INTERFERENCE SCREW
Instrument Makar, Inc.
MAI
Jul 21, 1994K933948ACUFEX ENDOBUTTON SYSTEM
Acufex Microsurgical, Inc.
MAI

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