Screw, Fixation, Intraosseous
Regulation 872.4880
1510(k)s in 12 months (81 all time)
0recalls in 12 months (8 all time)
8recalls that name a 510(k)
Top companies in DZL
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes (Usa) | 13 | 0 |
| Hager& Meisinger GmbH | 5 | 0 |
| Osteomed | 5 | 0 |
| KLS Martin L.P. | 4 | 0 |
| Synthes USA HQ, Inc. | 0 | 4 |
| BioHorizons Implant Systems, Inc. | 3 | 0 |
| Biomet, Inc. | 3 | 0 |
| Mitek Products | 3 | 0 |
| Osstem Implant Co., Ltd. | 3 | 0 |
| Salvin Dental Specialties | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 1999 | K980760 | KLS-MARTIN MMF SCREW KLS-Martin L.P. | DZL |
| Dec 16, 1999 | K993327 | TALON ANCHOR SNAP-PAK Mitek Products | DZL |
| Nov 2, 1999 | K992623 | MITEK MINI ANCHOR Mitek Products | DZL |
| Jun 21, 1999 | K982951 | IMTEC BIOPIN Imtec Corp. | DZL |
| May 13, 1999 | K983728 | LORENZ IMF SCREW Walter Lorenz Surgical, Inc. | DZL |
| Dec 21, 1998 | K983485 | SYNTHES 1.3 MM SELF-DRILLING SCREW Synthes (Usa) | DZL |
| Dec 2, 1998 | K981881 | DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING Doctor'S Research Group, Inc. | DZL |
| Nov 3, 1998 | K981666 | 2.5 MM LACTOSORB SCREWS Biomet, Inc. | DZL |
| Sep 8, 1998 | K982927 | QUICK TAP SELF DRILLING SCREW Kinamed, Inc. | DZL |
| Jul 14, 1998 | K981459 | MEMBRANE TACK Biomet, Inc. | DZL |
| Jun 29, 1998 | K981362 | SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR Synthes (Usa) | DZL |
| Apr 17, 1998 | K980199 | SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS Synthes (Usa) | DZL |
| Mar 13, 1998 | K974817 | DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM Doctor'S Research Group, Inc. | DZL |
| Jan 30, 1998 | K974392 | LEADFIX BIORESORBABLE MEMBRANCE PIN SYSTEM Biovision GmbH | DZL |
| Dec 23, 1997 | K972480 | 3I BIORESORBABLE FIXATION TACK Implant Innovations, Inc. | DZL |
| Nov 18, 1997 | K973180 | IMTEC BONE TAC Imtec Corp. | DZL |
| Nov 12, 1997 | K973056 | BONE GRAFT SCREW SYSTEM Bicon, Inc. | DZL |
| Oct 10, 1997 | K962774 | OSTEOMED QUICKFIX Osteomed Corp. | DZL |
| Jun 24, 1997 | K963546 | SMF TITANIUM (TI) ALLOY BONE SCREWS Synthes (Usa) | DZL |
| Apr 11, 1997 | K964261 | SMF STAINLESS STEEL BONE SCREWS Synthes (Usa) | DZL |
| Oct 25, 1996 | K961418 | OSTEOMED MSS Osteomed Corp. | DZL |
| May 24, 1996 | K960945 | IMZ MEMBRANE TACK SYSTEM Interpore Intl. | DZL |
| Jan 23, 1996 | K955369 | MEMFIX The Straumann Co. | DZL |
| Jan 5, 1996 | K955140 | 2.0 X 6MM SCREW Brasseler USA I, L.P. | DZL |
| Nov 21, 1995 | K952167 | IMZ BONE TACK SYSTEM Interpore Intl. | DZL |
| Aug 25, 1995 | K951510 | ACE BONE SCREW TACKING KIT Ace Surgical Supply Co., Inc. | DZL |
| Sep 30, 1991 | K910427 | MEMFIX SCREWS W. L. Gore & Associates, Inc. | DZL |
| Aug 21, 1991 | K911936 | OSTEOMED SBF SYSTEM (SBF) Osteomed Corp. | DZL |
| Aug 20, 1991 | K911165 | SCREW, BONE, MAXILLOFACIAL Tekno-Medical | DZL |
| Jan 28, 1977 | K770131 | LEW PROSTHETIC LOCKING DEVICE Howmedica Corp. | DZL |
| Dec 15, 1976 | K761228 | LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM Howmedica Corp. | DZL |
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