Howmedica Leibinger, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Howmedica Leibinger, Inc.” (first 1996, latest 1997), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 65 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Stryker, based on public ownership records.
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 | 5 | 5 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
Review panels
- Dental (6)
- Orthopedic (4)
- Neurology (1)
Most recent Howmedica Leibinger, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970912 | LEIBINGER SELF-DRILLING SCREW | HWC | 1997-10-01 | 203 |
| K972166 | GUERRERO - BELL DISTRACTOR | JEY | 1997-08-11 | 63 |
| K972154 | COHEN DISTRACTOR | JEY | 1997-08-11 | 63 |
| K961719 | EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES | HRS | 1997-07-17 | 441 |
| K970911 | LEE PLATE | JEY | 1997-04-11 | 30 |
| K963030 | LEIBINGER IMF SCREW | DZE | 1997-04-11 | 249 |
| K963741 | LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS | HRS | 1997-02-06 | 142 |
| K964649 | VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE | JEY | 1997-01-24 | 65 |
| K963739 | LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS | HWC | 1997-01-22 | 127 |
| K963740 | LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS | JEY | 1996-10-28 | 41 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Howmedica Leibinger, Inc..
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.
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.
- Howmedica Corp. (409 510(k)s)
- Howmedica Osteonics Corp. (301 510(k)s)
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics (32 510(k)s)
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (9 510(k)s)
- Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) (2 510(k)s)
- Howmedica Osteonics Corp (Dba Stryker Orthopaedics) (1 510(k)s)
- Howmedica Osteonics Corp. Dba Stryker Orthopeadics (1 510(k)s)
- Howmedica Osteonics, Dba Stryker Orthopaedics (1 510(k)s)
- Howmedica, Pfizer Medical Technology Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Howmedica Leibinger, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Howmedica Leibinger, Inc.” (first 1996, latest 1997), across 5 product codes in 3 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 Howmedica Leibinger, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Howmedica Leibinger, Inc. is 65 days.
Which FDA product codes appear under Howmedica Leibinger, Inc.?
The most frequent FDA product codes under this applicant name are JEY (Plate, Bone, 5); HRS (Plate, Fixation, Bone, 2); HWC (Screw, Fixation, Bone, 2).
Next steps
- See all 11 Howmedica Leibinger, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JEY, Howmedica Leibinger, 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.