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)
Top companies in MAI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 8, 2003 | K032197 | TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 Smith & Nephew, Inc. | MAI |
| Jul 25, 2003 | K031981 | 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 Linvatec Biomaterials, Ltd. | MAI |
| Jun 6, 2003 | K031519 | CUFFLOK ANCHOR Mitek Worldwide | MAI |
| Nov 2, 2001 | K011985 | SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT Smith & Nephew, Inc. | MAI |
| Oct 29, 2001 | K012465 | MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR Bonutti Research, Inc. | MAI |
| Oct 12, 2001 | K013057 | BIOCUFF,C, MODELS 236018, 236028, 236036 Bionx Implants, Inc., FI | MAI |
| Sep 19, 2001 | K012334 | CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 Bionx Implants, Inc., FI | MAI |
| Aug 1, 2001 | K011495 | ARTHREX BIO-POST AND WASHER Arthrex, Inc. | MAI |
| Jun 27, 2001 | K011299 | SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR Smith & Nephew, Inc. | MAI |
| Mar 19, 2001 | K003984 | SUPER REVO SUTURE ANCHOR Linvatec Corp. | MAI |
| Feb 15, 2001 | K002406 | MITEK 2GII MENISCAL REPAIR SYSTEM Mitek Products | MAI |
| Feb 9, 2001 | K003743 | SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM Synthes (Usa) | MAI |
| Jan 12, 2001 | K003970 | CONTOUR LABRAL NAIL, MODEL 533520A Bionx Implants, Inc., FI | MAI |
| Jan 11, 2001 | K003273 | LACTOSORB SCREW ANCHOR Biomet, Inc. | MAI |
| Jan 8, 2001 | K003227 | BIO-ABSORBABLE CORKSCREW MODEL AR-1920B Arthrex, Inc. | MAI |
| Oct 27, 2000 | K003076 | MITEK CUFFTACK Mitek Products | MAI |
| Sep 19, 2000 | K002413 | ULTRASORB SUTURE ANCHOR Li Medical Technologies, Inc. | MAI |
| Aug 25, 2000 | K002020 | LACTOSORB MENISCAL SCREW Biomet Manufacturing, Inc. | MAI |
| Jul 28, 2000 | K994161 | SYNTHES BIORESORBABLE SUTURE ANCHOR Synthes (Usa) | MAI |
| Jul 28, 2000 | K001378 | BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 Bionx Implants, Inc., FI | MAI |
| May 1, 2000 | K000506 | BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B Arthrex, Inc. | MAI |
| Mar 23, 2000 | K000616 | SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 Bionx Implants, Ltd., FI | MAI |
| Jan 28, 2000 | K990340 | ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU Arthrex, Inc. | MAI |
| Jan 13, 2000 | K990987 | BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B Arthrex, Inc. | MAI |
| Jan 10, 2000 | K994269 | TITAN RC TACK Innovasive Devices, Inc. | MAI |
| Dec 17, 1999 | K993115 | MULTITAK SS Bonutti Research, Inc. | MAI |
| Dec 10, 1999 | K993339 | ENDOPEARL WITH THREADER Linvatec Corp. | MAI |
| Dec 10, 1999 | K993074 | SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 Bionx Implants, Ltd., FI | MAI |
| Dec 6, 1999 | K993073 | SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 Bionx Implants, Ltd., FI | MAI |
| Nov 19, 1999 | K993061 | STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM Stryker Instruments | MAI |
| Nov 9, 1999 | K993453 | MENISCUS ARROW, MODELS 531110, 531113, 531116 Bionx Implants, Ltd., FI | MAI |
| Oct 27, 1999 | K993373 | ROTORBLADE SUTURE ANCHOR Li Medical Technologies, Inc. | MAI |
| Sep 23, 1999 | K992938 | ROTORBLADE SUTURE ANCHOR Li Medical Technologies, Inc. | MAI |
| Aug 27, 1999 | K992567 | ANATOMICAL BANKART TACK, MODEL 523520A Bionx Implants, Ltd., FI | MAI |
| Aug 13, 1999 | K983577 | ARTHREX MENISCAL DART SYSTEM Arthrex, Inc. | MAI |
| Aug 6, 1999 | K991715 | BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE Linvatec Corp. | MAI |
| Jun 23, 1999 | K991009 | RC BUTTRESS Biomet, Inc. | MAI |
| Apr 29, 1999 | K984171 | ENDOPEARL Linvatec Corp. | MAI |
| Apr 29, 1999 | K983435 | ROTORBLADE Li Medical Technologies, Inc. | MAI |
| Apr 14, 1999 | K990999 | MODIFICATION OF: EBI SPINELINK SYSTEM Electro-Biology, Inc. | MAI |
| Apr 14, 1999 | K990361 | HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU Arthrex, Inc. | MAI |
| Mar 12, 1999 | K983843 | BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B Arthrex, Inc. | MAI |
| Mar 1, 1999 | K984490 | SUTURELESS ANCHOR Innovasive Devices, Inc. | MAI |
| Jan 27, 1999 | K982095 | LACTOSORB MENISCAL REPAIR DEVICE Biomet, Inc. | MAI |
| Oct 21, 1998 | K983186 | BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR Linvatec Corp. | MAI |
| Aug 31, 1998 | K982900 | PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW Depuy, Inc. | MAI |
| Jun 22, 1998 | K981340 | INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM Innovasive Devices, Inc. | MAI |
| Apr 14, 1998 | K972783 | BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR Bionx Implants, Inc. | MAI |
| Mar 20, 1998 | K974876 | BIONX DISTAL RADIUS SCREW Bionx Implants, Inc. | MAI |
| Feb 18, 1998 | K973381 | BIOROC EZ SUTURE BONE FASTENER Innovasive Devices, Inc. | MAI |
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