Company ยท US
Walter Lorenz Surgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2007. Name variants (Inc, Corp, punctuation) are merged.
56510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JEY | Plate, Bone | 18 |
| HRS | Plate, Fixation, Bone | 6 |
| MQN | External Mandibular Fixator And/Or Distractor | 6 |
| HWC | Screw, Fixation, Bone | 4 |
| DZL | Screw, Fixation, Intraosseous | 2 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 |
| HAW | Neurological Stereotaxic Instrument | 2 |
| NEU | Marker, Radiographic, Implantable | 2 |
| DXC | Clamp, Vascular | 1 |
| DZE | Implant, Endosseous, Root-Form | 1 |
| EKW | Broach, Endodontic | 1 |
| EMH | Forceps, Rongeur, Surgical | 1 |
| FWN | Prosthesis, Larynx (Stents And Keels) | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 |
| HRX | Arthroscope | 1 |
| LYA | Splint, Intranasal Septal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 9, 2007 | K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM Walter Lorenz Surgical, Inc. | OAT |
| Jan 12, 2007 | K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES Walter Lorenz Surgical, Inc. | JEY |
| Dec 18, 2006 | K063506 | LORENZ STERNAL CLOSURE SYSTEM Walter Lorenz Surgical, Inc. | HRS |
| Dec 4, 2006 | K062842 | TWIST DRILL Walter Lorenz Surgical, Inc. | HBE |
| Jun 6, 2006 | K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM Walter Lorenz Surgical, Inc. | HRS |
| Nov 8, 2004 | K042516 | OTOMIMIX Walter Lorenz Surgical, Inc. | NEA |
| May 14, 2004 | K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER Walter Lorenz Surgical, Inc. | JEY |
| May 13, 2004 | K040990 | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS Walter Lorenz Surgical, Inc. | NEU |
| May 5, 2004 | K040983 | LORENZ SELF-DRILLING IMF SCREW Walter Lorenz Surgical, Inc. | DZE |
| Dec 15, 2003 | K033740 | LORENZ STERNAL CLOSURE SYSTEM Walter Lorenz Surgical, Inc. | HWC |
| Aug 11, 2003 | K032228 | LORENZ 2.4 SELF DRILLING SCREWS Walter Lorenz Surgical, Inc. | HWC |
| Jun 26, 2003 | K031751 | RAPIDFIRE SELF DRILLING SCREWS Walter Lorenz Surgical, Inc. | HWC |
| Jun 17, 2003 | K031696 | LORENZE EXTERNAL MANDIBULAR DISTRACTOR Walter Lorenz Surgical, Inc. | MQN |
| May 21, 2003 | K031034 | SPIN DOWN RAPIDFLAP Walter Lorenz Surgical, Inc. | GXN |
| Dec 4, 2002 | K023718 | QUICKSET MIMIX BONE VOID FILLER Walter Lorenz Surgical, Inc. | GXP |
| May 21, 2002 | K021522 | LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW Walter Lorenz Surgical, Inc. | DZL |
| Feb 28, 2002 | K013954 | LORENZ SELF DRILLING SCREWS Walter Lorenz Surgical, Inc. | HWC |
| Feb 22, 2002 | K020407 | LORENZ BLUE DEVICE Walter Lorenz Surgical, Inc. | MQN |
| Jan 17, 2002 | K014148 | SELF-DRILLING RADIOGRAPHIC MARKER Walter Lorenz Surgical, Inc. | NEU |
| Nov 16, 2001 | K013557 | LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW Walter Lorenz Surgical, Inc. | MBI |
| Oct 18, 2001 | K012409 | LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS Walter Lorenz Surgical, Inc. | NHB |
| Aug 6, 2001 | K002790 | ADD-ON CONDYLE Walter Lorenz Surgical, Inc. | NEI |
| Jul 16, 2001 | K011076 | LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW Walter Lorenz Surgical, Inc. | HRS |
| Apr 13, 2001 | K002131 | LACTOSORB ETHMOID STENT Walter Lorenz Surgical, Inc. | LYA |
| Mar 15, 2001 | K010427 | LORENZ FIDUCAIL SCREW Walter Lorenz Surgical, Inc. | HAW |
| Feb 12, 2001 | K002083 | LORENZ RESORBABLE DISTRACTOR SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| May 3, 2000 | K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Nov 19, 1999 | K992952 | LORENZ DISTRACTION SYSTEM Walter Lorenz Surgical, Inc. | MQN |
| Nov 8, 1999 | K992961 | LORENZ SMALL FRAGMENT SYSTEM Walter Lorenz Surgical, Inc. | HRS |
| Sep 17, 1999 | K992873 | LORENZ EXTERNAL MANDIBULAR DISTRACTOR Walter Lorenz Surgical, Inc. | MQN |
| Sep 14, 1999 | K992050 | LUMENON XENON LIGHT SOURCE Walter Lorenz Surgical, Inc. | GCT |
| May 13, 1999 | K983728 | LORENZ IMF SCREW Walter Lorenz Surgical, Inc. | DZL |
| Apr 23, 1999 | K991029 | RAPIDFLAP CRANIAL CLAMP Walter Lorenz Surgical, Inc. | GXN |
| Nov 12, 1998 | K982906 | LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM Walter Lorenz Surgical, Inc. | MQN |
| Oct 23, 1998 | K982604 | LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM Walter Lorenz Surgical, Inc. | MQN |
| Jul 13, 1998 | K981789 | LORENZ PECTUS SUPPORT BAR STABILIZER Walter Lorenz Surgical, Inc. | HRS |
| May 11, 1998 | K980512 | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW Walter Lorenz Surgical, Inc. | JEY |
| Feb 23, 1998 | K973080 | SURGICAL VASCULAR CLAMP Walter Lorenz Surgical, Inc. | DXC |
| Aug 18, 1997 | K972322 | LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES Walter Lorenz Surgical, Inc. | JEY |
| Aug 11, 1997 | K972420 | LORENZ PECTUS SUPPORT BAR Walter Lorenz Surgical, Inc. | HRS |
| Jul 25, 1997 | K972074 | SUCTION INSTRUMENTATION Walter Lorenz Surgical, Inc. | GCX |
| Sep 28, 1995 | K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Dec 23, 1992 | K922741 | LORENZ 1.0 MM SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Feb 20, 1991 | K910038 | LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Feb 22, 1990 | K896667 | LORENZ STENT Walter Lorenz Surgical, Inc. | FWN |
| Jun 22, 1988 | K881403 | MCCAIN MONOPOLAR & BIPOLAR CAUTERY Walter Lorenz Surgical, Inc. | GEI |
| Feb 24, 1988 | K874911 | MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG Walter Lorenz Surgical, Inc. | HRX |
| Feb 12, 1988 | K872877 | TARGET PROGRAM & EPSON HX-20 COMPUTER Walter Lorenz Surgical, Inc. | HAW |
| Sep 5, 1986 | K862532 | DUMBACH TITANIUM MESH IMPLANT SYSTEM Walter Lorenz Surgical, Inc. | JEY |
| Aug 7, 1986 | K862534 | PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS Walter Lorenz Surgical, Inc. | JEY |
Newest 50 of 56.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Walter Lorenz Surgical, Inc. Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."
W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPOR Terminated |
JEY | K002083 |
| Jan 11, 2012 | Walter Lorenz Surgical, Inc. Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."
W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRAD Terminated |
JEY | K002083 |
| Jan 11, 2012 | Walter Lorenz Surgical, Inc. Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."
W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 T Terminated |
JEY | K002083 |