# Zavation, LLC

- Location (FDA's records): Flowood, MS
- FDA decisions: 15 (2011–2017): 15 510(k) clearances
- Product codes: KWQ (4), MAX (3), OVE (1), MNI (1), PEK (1), NKG (1), OVD (1), NDN (1), MNH (1), ODP (1)
- 510(k) review time since 2016: median 159 days, against 112 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 45 (8 its own); citations of its devices by later devices: 32 (8 its own)
- Recalls linked to its devices: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes Spine: 8 (https://510kreport.com/company/synthes-spine)
- Ldr Spine USA: 4 (https://510kreport.com/company/ldr-spine-usa)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Depuy, Inc.: 2 (https://510kreport.com/company/depuy)
- Orthofix, Inc.: 1 (https://510kreport.com/company/orthofix)
- Spine Smith Partners L.P.: 1 (https://510kreport.com/company/spine-smith-partners)
- Spineart: 1 (https://510kreport.com/company/spineart)

## Firms that cite its devices most
- Zavation Medical Products, LLC: 13 (https://510kreport.com/company/zavation-medical-products)
- Amendia, Inc.: 2 (https://510kreport.com/company/amendia)
- Ulrich Medical USA: 2 (https://510kreport.com/company/ulrich-medical-usa)
- Safe Orthopaedics: 1 (https://510kreport.com/company/safe-orthopaedics)
- K2m, Inc.: 1 (https://510kreport.com/company/k2m)
- Spinenet, LLC: 1 (https://510kreport.com/company/spinenet)
- Met One Technologies, LLC: 1 (https://510kreport.com/company/met-one-technologies)
- Fellowship of Orthopaedic Researchers, Inc.: 1 (https://510kreport.com/company/fellowship-of-orthopaedic-researchers)

## Its most-cited devices
- K130030: Zavation Cervical Plate System (2013), cited by 6
- K112533: Zavation Cervical Plate System (2011), cited by 5
- K120576: Zavation Ibf System (2012), cited by 4
- K112484: Zavation Spinal System (2011), cited by 3
- K112664: Zavation Ibf Systems (2011), cited by 3
- K160362: Z-Span Plate System (2016), cited by 2

## Recent decisions
- K162206: Zavation IBF (Apr 4, 2017)
- K162575: Z-LINKPC System (Mar 3, 2017)
- K162824: Z-Span Plate System (Feb 17, 2017)
- K161016: Z-Clamp ISP System (Oct 19, 2016)
- K153404: Zavation Spinal System (Apr 21, 2016)
- K160362: Z-Span Plate System (Mar 22, 2016)
- K142392: Zavation Posterior LEIF (Apr 29, 2015)
- K142271: Zavation Z-Link Lumbar (Dec 19, 2014)

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