Walter Lorenz Surgical, Inc.: FDA filings under this applicant name
FDA lists 56 510(k) clearances under the applicant name “Walter Lorenz Surgical, Inc.” (first 1986, latest 2007), across 25 product codes in 8 review panels. Median 510(k) review time under this name: 54 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JEY | Plate, Bone | 15 | 15 |
| HRS | Plate, Fixation, Bone | 6 | 6 |
| MQN | External Mandibular Fixator And/Or Distractor | 6 | 6 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| DZL | Screw, Fixation, Intraosseous | 2 | 2 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| NEU | Marker, Radiographic, Implantable | 2 | 2 |
| DXC | Clamp, Vascular | 1 | 1 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
Plus 15 more product codes.
Review panels
- Dental (28)
- Orthopedic (12)
- Neurology (6)
- Ear, Nose and Throat (4)
- General and Plastic Surgery (3)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent Walter Lorenz Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | OAT | 2007-02-09 | 93 |
| K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | JEY | 2007-01-12 | 100 |
| K063506 | LORENZ STERNAL CLOSURE SYSTEM | HRS | 2006-12-18 | 28 |
| K062842 | TWIST DRILL | HBE | 2006-12-04 | 73 |
| K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM | HRS | 2006-06-06 | 19 |
| K042516 | OTOMIMIX | NEA | 2004-11-08 | 53 |
| K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | JEY | 2004-05-14 | 459 |
| K040990 | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS | NEU | 2004-05-13 | 27 |
| K040983 | LORENZ SELF-DRILLING IMF SCREW | DZE | 2004-05-05 | 20 |
| K033740 | LORENZ STERNAL CLOSURE SYSTEM | HWC | 2003-12-15 | 17 |
46 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-02-17.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Walter Lorenz Surgical, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Walter Abendschein, M.D. (5 510(k)s)
- Walter Ansted Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Walter Lorenz Surgical, Inc.?
FDA lists 56 510(k) clearances under the applicant name “Walter Lorenz Surgical, Inc.” (first 1986, latest 2007), across 25 product codes in 8 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Walter Lorenz Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Walter Lorenz Surgical, Inc. is 54 days.
Which FDA product codes appear under Walter Lorenz Surgical, Inc.?
The most frequent FDA product codes under this applicant name are JEY (Plate, Bone, 15); HRS (Plate, Fixation, Bone, 6); MQN (External Mandibular Fixator And/Or Distractor, 6).
Next steps
- See all 56 Walter Lorenz Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JEY, Walter Lorenz Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.