ClearanceBrief
Panels › Orthopedic › Product code HTN · Class 2

Washer, Bolt Nut

Regulation 888.3030

3510(k)s in 12 months (93 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in HTN

Company510(k)sRecalls
Arthrex, Inc.161
Dallen Medical, Inc.50
Synthes (Usa)50
Acu Med, Inc.40
Acumed, LLC40
Akros Medical30
Buckman Co., Inc.30
Instratek, Inc.30
TriMed, Inc.21
Arthrosurface, Inc.20
Decided510(k)Device and applicantCode
Jul 23, 2013K130986FRAG-LOC SYSTEM
Acumed, LLC
HTN
Dec 21, 2011K112437ARTHREX FRACTURE SYSTEM
Arthrex, Inc.
HTN
Nov 14, 2011K112111ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
Acumed, LLC
HTN
Aug 31, 2011K111032CMC CABLE FIX
Instratek, Inc.
HTN
Feb 15, 2011K091207SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE
Surgicraft , Ltd.
HTN
Sep 11, 2009K091799CABLE READY CABLE GRIP SYSTEM CABLE BUTTON
Zimmer, Inc.
HTN
Aug 14, 2009K091763MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000
Instratek, Inc.
HTN
Aug 6, 2009K090107MINI TIGHTROPE
Arthrex, Inc.
HTN
Dec 8, 2008K082384HAV-LOK BUNION CORRECTION SYSTEM
Instratek, Inc.
HTN
Oct 21, 2008K082095ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
Smith & Nephew Endoscopy, Inc.
HTN
Aug 15, 2007K071978MINI TIGHTROPE FT REPAIR KIT
Arthrex, Inc.
HTN
Oct 31, 2006K061925MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS
Arthrex, Inc.
HTN
Dec 13, 2005K052776TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD
Arthrex, Inc.
HTN
Feb 18, 2005K043145BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
Arthrex, Inc.
HTN
Feb 17, 2005K043411RESOFIX BIOABSORBABLE EXPANSION BOLT
Resofix, Inc.
HTN
Feb 16, 2005K043248TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS
Arthrex, Inc.
HTN
Mar 23, 2004K040250BONE-LOK HP WASHER
Triage Medical, Inc.
HTN
Apr 1, 2003K030619ODI 7.0MM CANNULATED SCREW SYSTEM
Orthopedic Designs, Inc.
HTN
Dec 18, 2002K023119BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
Arthrex, Inc.
HTN
Feb 8, 2002K013806SYNTHES METALLIC SPIKED WASHERS
Synthes (Usa)
HTN
Jan 30, 2002K011583SPIKED WASHER
Synthes (Usa)
HTN
Feb 8, 2001K003496CANNULATED SCREW SYSTEM
Pioneer Surgical Technology
HTN
Oct 27, 1999K992617HEX BUTTON
Pioneer Surgical Technology
HTN
Apr 29, 1999K991135SOFT TISSUE SUTURE WASHER
Depuy, Inc.
HTN
Dec 18, 1998K983906DEPUY ORTHOTECH SPIKED WASHER
DePuy Orthopaedics, Inc.
HTN
Nov 23, 1998K982354SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M
Special Devices, Inc.
HTN
Oct 26, 1998K983265DEPUY ACE COMPOSITE LOCKING NUT
Depuy Ace Medical Co.
HTN
Apr 27, 1998K980944SYNTHES SCHUHLI IMPLANT SYSTEM
Synthes (Usa)
HTN
Mar 17, 1997K965028ACUMED SUTURE WASHER
Acu Med, Inc.
HTN
Nov 15, 1996K963420CANCELLOUS SCREW WASHER
Orthopaedic Biosystems, Ltd.
HTN
Feb 9, 1996K954682WASHER, BOLT, NUT, ORTHOPEDIC
Linvatec Corp.
HTN
Jan 17, 1996K954148SUTURE WASHER
Acu Med, Inc.
HTN
Dec 20, 1994K943782BONE SCREW WASHER
Acu Med, Inc.
HTN
May 12, 1993K924455SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER
Synthes (Usa)
HTN
Nov 7, 1991K914472SPIKED WASHER
Synthes (Usa)
HTN
Sep 10, 1991K911306T-BOLT AND NUT
Danek Medical, Inc.
HTN
Jul 25, 1991K910186WYMAN SUTURE WASHER
Acu Med, Inc.
HTN
Jul 24, 1991K910229SOFT TISSUE SUTURE WASHER/3 HOLE WASHER
Depuy, Inc.
HTN
Sep 11, 1989K895107ACE ORTHOPAEDIC WASHERS
Buckman Co., Inc.
HTN
Apr 27, 1988K881699ACROMED WASHERS
Buckman Co., Inc.
HTN
Dec 11, 1987K874669ACE BONE SCREW NUT
Buckman Co., Inc.
HTN
Sep 12, 1984K843368KAPP SPINAL BUTTON
Kapp Surgical Instrument, Inc.
HTN
Jan 17, 1984K834411TECHMEDICA-HEWSON SHOULDER CLEAT
Techmedica, Inc.
HTN

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