# Howmedica Leibinger, Inc.

- Location (FDA's records): Dallas, TX
- FDA decisions: 11 (1996–1997): 11 510(k) clearances
- Product codes: JEY (5), HRS (2), HWC (2), HAW (1), DZE (1)
- Predicates its devices cite: 36 (6 its own); citations of its devices by later devices: 33 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Howmedica Corp.: 15 (https://510kreport.com/company/howmedica)
- Walter Lorenz Surgical, Inc.: 6 (https://510kreport.com/company/walter-lorenz-surgical)
- Synthes (Usa): 5 (https://510kreport.com/company/synthes-usa)
- Wells Johnson Co.: 1 (https://510kreport.com/company/wells-johnson)
- KLS-Martin L.P.: 1 (https://510kreport.com/company/kls-martin)
- Leibinger & Fischer, Ltd.: 1 (https://510kreport.com/company/leibinger-fischer)
- Unisplint Corp.: 1 (https://510kreport.com/company/unisplint)

## Firms that cite its devices most
- Osteomed LP: 7 (https://510kreport.com/company/osteomed)
- Walter Lorenz Surgical, Inc.: 4 (https://510kreport.com/company/walter-lorenz-surgical)
- Howmedica Corp.: 3 (https://510kreport.com/company/howmedica)
- Stryker Craniomaxillofacial: 2 (https://510kreport.com/company/stryker-craniomaxillofacial)
- Azary Technologies, LLC: 1 (https://510kreport.com/company/azary-technologies)
- Stryker Instruments: 1 (https://510kreport.com/company/stryker-instruments)
- Medicon EG: 1 (https://510kreport.com/company/medicon-eg)
- Medartis AG: 1 (https://510kreport.com/company/medartis)

## Its most-cited devices
- K972154: Cohen Distractor (1997), cited by 5
- K964649: Vazquez Diner Intraoral Distraction Device (1997), cited by 5
- K963030: Leibinger Imf Screw (1997), cited by 5
- K972166: Guerrero - Bell Distractor (1997), cited by 4
- K970912: Leibinger Self-Drilling Screw (1997), cited by 4
- K961120: Marker System for Stereotaxic Navigation (1996), cited by 4

## Recent decisions
- K970912: Leibinger Self-Drilling Screw (Oct 1, 1997)
- K972166: Guerrero - Bell Distractor (Aug 11, 1997)
- K972154: Cohen Distractor (Aug 11, 1997)
- K961719: Epitec Titanium Implant System for the Surgical Anchoring of Facial Prostheses (Jul 17, 1997)
- K970911: Lee Plate (Apr 11, 1997)
- K963030: Leibinger Imf Screw (Apr 11, 1997)
- K963741: Leibinger Luhr Small Craniomaxillofacial Bone Screws (Feb 6, 1997)
- K964649: Vazquez Diner Intraoral Distraction Device (Jan 24, 1997)

Source page: https://510kreport.com/company/howmedica-leibinger