Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Walter Lorenz Surgical, Inc. · Predicate Candidate Screening
56 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
203 days90th percentile
56clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | Walter Lorenz Surgical, Inc. | 2007-02-09 | 93 | 0 |
| K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BE | Walter Lorenz Surgical, Inc. | 2007-01-12 | 100 | 0 |
| K063506 | LORENZ STERNAL CLOSURE SYSTEM | Walter Lorenz Surgical, Inc. | 2006-12-18 | 28 | 0 |
| K062842 | TWIST DRILL | Walter Lorenz Surgical, Inc. | 2006-12-04 | 73 | 1 |
| K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT B | Walter Lorenz Surgical, Inc. | 2006-06-06 | 19 | 0 |
| K042516 | OTOMIMIX | Walter Lorenz Surgical, Inc. | 2004-11-08 | 53 | 0 |
| K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | Walter Lorenz Surgical, Inc. | 2004-05-14 | 459 | 0 |
| K040990 | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS | Walter Lorenz Surgical, Inc. | 2004-05-13 | 27 | 0 |
| K040983 | LORENZ SELF-DRILLING IMF SCREW | Walter Lorenz Surgical, Inc. | 2004-05-05 | 20 | 0 |
| K033740 | LORENZ STERNAL CLOSURE SYSTEM | Walter Lorenz Surgical, Inc. | 2003-12-15 | 17 | 0 |
| K032228 | LORENZ 2.4 SELF DRILLING SCREWS | Walter Lorenz Surgical, Inc. | 2003-08-11 | 21 | 0 |
| K031751 | RAPIDFIRE SELF DRILLING SCREWS | Walter Lorenz Surgical, Inc. | 2003-06-26 | 21 | 1 |
| K031696 | LORENZE EXTERNAL MANDIBULAR DISTRACTOR | Walter Lorenz Surgical, Inc. | 2003-06-17 | 15 | 0 |
| K031034 | SPIN DOWN RAPIDFLAP | Walter Lorenz Surgical, Inc. | 2003-05-21 | 50 | 0 |
| K023718 | QUICKSET MIMIX BONE VOID FILLER | Walter Lorenz Surgical, Inc. | 2002-12-04 | 29 | 0 |
| K021522 | LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW | Walter Lorenz Surgical, Inc. | 2002-05-21 | 11 | 0 |
| K013954 | LORENZ SELF DRILLING SCREWS | Walter Lorenz Surgical, Inc. | 2002-02-28 | 90 | 0 |
| K020407 | LORENZ BLUE DEVICE | Walter Lorenz Surgical, Inc. | 2002-02-22 | 16 | 0 |
| K014148 | SELF-DRILLING RADIOGRAPHIC MARKER | Walter Lorenz Surgical, Inc. | 2002-01-17 | 30 | 0 |
| K013557 | LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW | Walter Lorenz Surgical, Inc. | 2001-11-16 | 23 | 0 |
| K012409 | LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS | Walter Lorenz Surgical, Inc. | 2001-10-18 | 80 | 0 |
| K002790 | ADD-ON CONDYLE | Walter Lorenz Surgical, Inc. | 2001-08-06 | 333 | 0 |
| K011076 | LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW | Walter Lorenz Surgical, Inc. | 2001-07-16 | 98 | 0 |
| K002131 | LACTOSORB ETHMOID STENT | Walter Lorenz Surgical, Inc. | 2001-04-13 | 273 | 0 |
| K010427 | LORENZ FIDUCAIL SCREW | Walter Lorenz Surgical, Inc. | 2001-03-15 | 30 | 0 |
| K002083 | LORENZ RESORBABLE DISTRACTOR SYSTEM | Walter Lorenz Surgical, Inc. | 2001-02-12 | 217 | 3 |
| K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM | Walter Lorenz Surgical, Inc. | 2000-05-03 | 15 | 1 |
| K992952 | LORENZ DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. | 1999-11-19 | 79 | 0 |
| K992961 | LORENZ SMALL FRAGMENT SYSTEM | Walter Lorenz Surgical, Inc. | 1999-11-08 | 67 | 0 |
| K992873 | LORENZ EXTERNAL MANDIBULAR DISTRACTOR | Walter Lorenz Surgical, Inc. | 1999-09-17 | 22 | 0 |
| K992050 | LUMENON XENON LIGHT SOURCE | Walter Lorenz Surgical, Inc. | 1999-09-14 | 89 | 0 |
| K983728 | LORENZ IMF SCREW | Walter Lorenz Surgical, Inc. | 1999-05-13 | 203 | 0 |
| K991029 | RAPIDFLAP CRANIAL CLAMP | Walter Lorenz Surgical, Inc. | 1999-04-23 | 25 | 0 |
| K982906 | LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. | 1998-11-12 | 86 | 0 |
| K982604 | LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM | Walter Lorenz Surgical, Inc. | 1998-10-23 | 88 | 0 |
| K981789 | LORENZ PECTUS SUPPORT BAR STABILIZER | Walter Lorenz Surgical, Inc. | 1998-07-13 | 54 | 0 |
| K980512 | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW | Walter Lorenz Surgical, Inc. | 1998-05-11 | 90 | 0 |
| K973080 | SURGICAL VASCULAR CLAMP | Walter Lorenz Surgical, Inc. | 1998-02-23 | 189 | 0 |
| K972322 | LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES | Walter Lorenz Surgical, Inc. | 1997-08-18 | 59 | 1 |
| K972420 | LORENZ PECTUS SUPPORT BAR | Walter Lorenz Surgical, Inc. | 1997-08-11 | 45 | 0 |
| K972074 | SUCTION INSTRUMENTATION | Walter Lorenz Surgical, Inc. | 1997-07-25 | 52 | 0 |
| K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM | Walter Lorenz Surgical, Inc. | 1995-09-28 | 71 | 8 |
| K922741 | LORENZ 1.0 MM SYSTEM | Walter Lorenz Surgical, Inc. | 1992-12-23 | 198 | 0 |
| K910038 | LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM | Walter Lorenz Surgical, Inc. | 1991-02-20 | 47 | 0 |
| K896667 | LORENZ STENT | Walter Lorenz Surgical, Inc. | 1990-02-22 | 87 | 0 |
| K881403 | MCCAIN MONOPOLAR & BIPOLAR CAUTERY | Walter Lorenz Surgical, Inc. | 1988-06-22 | 79 | 0 |
| K874911 | MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG | Walter Lorenz Surgical, Inc. | 1988-02-24 | 84 | 0 |
| K872877 | TARGET PROGRAM & EPSON HX-20 COMPUTER | Walter Lorenz Surgical, Inc. | 1988-02-12 | 206 | 0 |
| K862532 | DUMBACH TITANIUM MESH IMPLANT SYSTEM | Walter Lorenz Surgical, Inc. | 1986-09-05 | 65 | 0 |
| K862534 | PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS | Walter Lorenz Surgical, Inc. | 1986-08-07 | 36 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda