Panels › Orthopedic › Product code MBI · Class 2
Fastener, Fixation, Nondegradable, Soft Tissue
Regulation 888.3040
33510(k)s in 12 months (607 all time)
0recalls in 12 months (113 all time)
104recalls that name a 510(k)
Top companies in MBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Arthrex, Inc. | 53 | 1 |
| ArthroCare Corporation | 31 | 1 |
| Axya Medical, Inc. | 5 | 24 |
| Smith & Nephew | 23 | 5 |
| Riverpoint Medical | 23 | 1 |
| Parcus Medical | 23 | 0 |
| Innovasive Devices, Inc. | 22 | 0 |
| Biomet, Inc. | 10 | 10 |
| CONMED Corporation | 16 | 1 |
| Stryker | 10 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2001 | K013553 | PRE-LOADED ULTRAFIX RC Linvatec Corp. | MBI |
| Dec 13, 2001 | K013334 | ENDOFLIP Arthocare Corporation, GB | MBI |
| Nov 16, 2001 | K013557 | LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW Walter Lorenz Surgical, Inc. | MBI |
| Oct 22, 2001 | K012503 | METAL SCREW ANCHOR Biomet Manufacturing, Inc. | MBI |
| Aug 31, 2001 | K011912 | MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 Axya Medical, Inc. | MBI |
| Jun 12, 2001 | K011007 | TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 Arthrex, Inc. | MBI |
| Jun 6, 2001 | K011390 | BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM Disc-O-Tech Medical Technologies, Ltd., IL | MBI |
| May 14, 2001 | K010457 | ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 Arthrex, Inc. | MBI |
| Mar 26, 2001 | K002829 | DJ ORTHOPEDICS FEMORAL ANCHOR Dj Orthopedics, LLC | MBI |
| Mar 21, 2001 | K003971 | AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR Axya Medical, Inc. | MBI |
| Mar 21, 2001 | K003960 | DJ ORTHOPEDICS TIBIAL ANCHOR Dj Orthopedics, LLC | MBI |
| Feb 23, 2001 | K003648 | FREEDLAND TENSION SYSTEM Etzem Technologies, Inc., IL | MBI |
| Feb 9, 2001 | K010121 | STERILE BUTTON PLATE Synthes (Usa) | MBI |
| Nov 15, 2000 | K002600 | LITWIN CRUICATE ANCHOR Instrument Makar, Inc. | MBI |
| Mar 15, 2000 | K994364 | SYNTHES BUTTON PLATE Synthes (Usa) | MBI |
| Mar 1, 2000 | K000279 | STAPLETAC2 BONE ANCHOR SYSTEM American Medical Systems, Inc. | MBI |
| Jan 13, 2000 | K993657 | ACUMED SUTURE ANCHOR Acu Med, Inc. | MBI |
| Dec 2, 1999 | K993261 | TALON ANCHOR SNAP-PAK Mitek Products | MBI |
| Oct 14, 1999 | K992458 | RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 Innovasive Devices, Inc. | MBI |
| Oct 8, 1999 | K992377 | RC TACK Innovasive Devices, Inc. | MBI |
| Mar 5, 1999 | K990295 | BONE ANCHOR SYSTEM III (BAS III) Boston Scientific Corp | MBI |
| Mar 5, 1999 | K990156 | MULTITAK SS BUTTONS Bonutti Research | MBI |
| Feb 16, 1999 | K990160 | MICROTAC-BONE ANCHOR SYSTEM Influence, Inc. | MBI |
| Feb 1, 1999 | K990095 | STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM Influence, Inc. | MBI |
| Feb 1, 1999 | K982751 | IMPLEX SCREW AND WASHER SYSTEM Implex Corp. | MBI |
| Jan 28, 1999 | K983560 | INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER Innovasive Devices, Inc. | MBI |
| Jan 21, 1999 | K984200 | STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE R. Thomas Grotz, M.D., Inc. | MBI |
| Dec 18, 1998 | K983557 | STRYKER WEDGE SUTURE ANCHOR Stryker Endoscopy | MBI |
| Dec 16, 1998 | K983169 | POLYMER THREADED ANCHOR Orthopaedic Biosystems, Ltd. | MBI |
| Nov 23, 1998 | K983818 | MITEK FASTIN RC ANCHOR Mitek Products | MBI |
| Oct 13, 1998 | K983056 | INNOVASIVE TIBIAL FASTENER Innovasive Devices, Inc. | MBI |
| Sep 22, 1998 | K982571 | KSEA FLIPPTACK KARL STORZ Endoscopy-America, Inc. | MBI |
| Sep 14, 1998 | K982169 | SHERLOCK THREADED SUTURE ANCHOR (TIN COATED) Doctor'S Research Group, Inc. | MBI |
| Aug 31, 1998 | K982155 | SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM Influence, Inc. | MBI |
| Aug 6, 1998 | K974847 | 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 Arthrex, Inc. | MBI |
| Jul 27, 1998 | K981692 | MENISCAL REPAIR DEVICE Linvatec Corp. | MBI |
| Jul 17, 1998 | K981967 | WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE Arthrotek/Biomet, Inc. | MBI |
| Jul 13, 1998 | K981764 | LM ANCHOR Li Medical Technologies, Inc. | MBI |
| Jul 13, 1998 | K981755 | LM ANCHOR Li Medical Technologies, Inc. | MBI |
| Jul 13, 1998 | K981688 | ANSPACH SUTURE ANCHOR The Anspach Effort, Inc. | MBI |
| Jun 16, 1998 | K981193 | INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER Innovasive Devices, Inc. | MBI |
| May 11, 1998 | K980595 | DEPUY ORTHOTECH CATERA SUTURE ANCHOR DePuy Orthopaedics, Inc. | MBI |
| Apr 29, 1998 | K980491 | INNOVASIVE LINX TIBIAL LIGAMENT FASTENER Innovasive Devices, Inc. | MBI |
| Apr 27, 1998 | K980334 | INNOVASIVE 10MM LINX HT LIGAMENT FASTENER Innovasive Devices, Inc. | MBI |
| Apr 24, 1998 | K973874 | ACL CLIP-IN PLATE Innovasive Devices, Inc. | MBI |
| Apr 16, 1998 | K973775 | HARPOON SUTURE ANCHORS Biomet, Inc. | MBI |
| Mar 16, 1998 | K980103 | ACUMED SUTURE ANCHOR Acu Med, Inc. | MBI |
| Feb 18, 1998 | K974049 | INNOVASIVE LINX BT 10MM LIGAMENT FASTENER Innovasive Devices, Inc. | MBI |
| Feb 13, 1998 | K974345 | MITEK KNOTLESS ANCHOR Mitek Products | MBI |
| Feb 6, 1998 | K972326 | PEBA ANCHOR/SUTURE COMBINATION Orthopaedic Biosystems, Ltd. | MBI |
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