# Ulrich GmbH & Co. KG

- Location (FDA's records): Ulm, DE
- FDA decisions: 24 (2005–2025): 24 510(k) clearances
- Product codes: IZQ (7), MQP (3), NKB (3), KWQ (3), NKG (2), MAX (2), PQH (1), MNI (1), MNH (1), KWP (1)
- 510(k) review time since 2016: median 119 days, against 119 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 69 (13 its own); citations of its devices by later devices: 42 (13 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Blackstone Medical, Inc.: 4 (https://510kreport.com/company/blackstone-medical)
- Depuyacromed: 4 (https://510kreport.com/company/depuyacromed)
- Medtronic Sofamor Danek USA, Inc.: 4 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Aesculap, Inc.: 4 (https://510kreport.com/company/aesculap)
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Osteotech, Inc.: 3 (https://510kreport.com/company/osteotech)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Ulrich Medical USA: 6 (https://510kreport.com/company/ulrich-medical-usa)
- K2m, Inc.: 2 (https://510kreport.com/company/k2m)
- Alphatec Spine, Inc.: 2 (https://510kreport.com/company/alphatec-spine)
- Icotec AG: 2 (https://510kreport.com/company/icotec)
- Aesculap Implant System, Inc.: 2 (https://510kreport.com/company/aesculap-implant-system)
- Zavation Medical Products, LLC: 2 (https://510kreport.com/company/zavation-medical-products)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)
- Spine Wave, Inc.: 1 (https://510kreport.com/company/spine-wave)

## Its most-cited devices
- K060416: Obelisc Vertebral Body Replacement Device (2006), cited by 9
- K161032: neon3™  universal OCT spinal stabilization (2016), cited by 5
- K102853: Flamenco Spinal Fixation System (2011), cited by 4
- K123717: Ucentum (2013), cited by 3
- K150650: neon3 (2015), cited by 3
- K192117: Small VBR™ (2019), cited by 3

## Recent decisions
- K252281: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (Nov 18, 2025)
- K251295: ulrichINJECT CT Motion (XD 8000) (Nov 7, 2025)
- K241850: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (Aug 26, 2024)
- K233737: ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) (Apr 19, 2024)
- K210541: ulrichINJECT CT motion (Aug 6, 2021)
- K202227: Artus™ cervical plate system (Sep 14, 2020)
- K192872: ulrichINJECT CT Motion (Jul 2, 2020)
- K192117: Small VBR™ (Nov 1, 2019)

Source page: https://510kreport.com/company/ulrich