# Kalitec Direct, LLC

- Location (FDA's records): Orlando, FL
- FDA decisions: 9 (2011–2018): 9 510(k) clearances
- Product codes: ODP (2), KWQ (2), MNH (2), MAX (1), PEK (1), NKB (1)
- 510(k) review time since 2016: median 94 days, against 69 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 41 (3 its own); citations of its devices by later devices: 15 (3 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
- Stryker Spine: 10 (https://510kreport.com/company/stryker-spine)
- Cross Medical Products, Inc.: 4 (https://510kreport.com/company/cross-medical-products)
- Alphatec Spine, Inc.: 3 (https://510kreport.com/company/alphatec-spine)
- Spinal Elements, Inc.: 3 (https://510kreport.com/company/spinal-elements)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)
- Buckman Co., Inc.: 2 (https://510kreport.com/company/buckman)
- Depuy Spine, Inc.: 2 (https://510kreport.com/company/depuy-spine)
- Ht Medical, LLC: 1 (https://510kreport.com/company/ht-medical)

## Firms that cite its devices most
- Kalitec Medical, LLC: 5 (https://510kreport.com/company/kalitec-medical)
- Kalitec Direct, LLC Doing Business AS Kalitec Medical: 2 (https://510kreport.com/company/kalitec-direct-doing-business-as-kalitec-medical)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)
- Ht Medical D.B.A. Xenix Medical: 1 (https://510kreport.com/company/ht-medical-dba-xenix-medical)
- Kisco International: 1 (https://510kreport.com/company/kisco-international)
- Spinal Analytics & Geometrical Implant Co, LLC: 1 (https://510kreport.com/company/spinal-analytics-geometrical-implant)
- Sagico VA USA, LLC: 1 (https://510kreport.com/company/sagico-va-usa)

## Its most-cited devices
- K140678: Cosmolock Pedicle Screw System (2014), cited by 4
- K180401: TiWAVE-C™ Porous Titanium Cervical Cage (2018), cited by 3
- K123100: Intess Lumbar Cage (2013), cited by 2
- K172808: CosmoLock Pedicle Screw System (2017), cited by 2
- K170342: Ocata Anterior Cervical System (2017), cited by 1
- K163471: Kalitec Direct InSePtion™ MIS Fixation System (2017), cited by 1

## Recent decisions
- K180401: TiWAVE-C™ Porous Titanium Cervical Cage (Jun 14, 2018)
- K172808: CosmoLock Pedicle Screw System (Oct 25, 2017)
- K172086: Matira™ Anterior Cervical System (Sep 22, 2017)
- K170342: Ocata Anterior Cervical System (May 9, 2017)
- K163471: Kalitec Direct InSePtion™ MIS Fixation System (Mar 16, 2017)
- K140678: Cosmolock Pedicle Screw System (Jun 19, 2014)
- K133815: Intess Cervical Cage System (Apr 16, 2014)
- K123100: Intess Lumbar Cage (Mar 28, 2013)

Source page: https://510kreport.com/company/kalitec-direct