# Theken Surgical,Llc

- Location (FDA's records): Barberton, OH
- FDA decisions: 9 (1998–2005): 9 510(k) clearances
- Names in FDA's records: Theken Surgical,Llc (6); Theken Surgical (3)
- Product codes: KWQ (3), JDK (2), MQP (2), KWP (1), HWC (1)
- Predicates its devices cite: 17 (1 its own); citations of its devices by later devices: 31 (1 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
- Signus Medizintechnik GmbH: 3 (https://510kreport.com/company/signus-medizintechnik)
- Signus Medical, LLC: 2 (https://510kreport.com/company/signus-medical)
- Depuy Motech Acromed: 2 (https://510kreport.com/company/depuy-motech-acromed)
- Synthes: 2 (https://510kreport.com/company/synthes)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Sofamor Danek USA,Inc.: 1 (https://510kreport.com/company/sofamor-danek-usa)
- Depuy, Inc.: 1 (https://510kreport.com/company/depuy)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)

## Firms that cite its devices most
- Theken Spine, LLC: 14 (https://510kreport.com/company/theken-spine)
- SeaSpine Orthopedics Corporation: 4 (https://510kreport.com/company/seaspine-orthopedics)
- Ldr Spine USA: 1 (https://510kreport.com/company/ldr-spine-usa)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)
- Kalitec Direct, LLC: 1 (https://510kreport.com/company/kalitec-direct)
- Flexuspine, Inc.: 1 (https://510kreport.com/company/flexuspine)
- Qualgenix: 1 (https://510kreport.com/company/qualgenix)
- Amedica Corp.: 1 (https://510kreport.com/company/amedica)

## Its most-cited devices
- K032064: Theken Cpod/Lpod Vertebral Body Replacement System (2004), cited by 8
- K041592: Coral Spinal System (2004), cited by 8
- K050058: Theken Reveal VBR System (2005), cited by 7
- K010466: Tether Acfs (2001), cited by 6
- K983622: Bodyform Thoraco-Lumbar Fixation System (1998), cited by 2

## Recent decisions
- K050058: Theken Reveal VBR System (May 17, 2005)
- K041592: Coral Spinal System (Sep 16, 2004)
- K032064: Theken Cpod/Lpod Vertebral Body Replacement System (Feb 20, 2004)
- K012462: Theken Large Cement Restrictor (Oct 29, 2001)
- K012278: Theken Small Cement Restrictor (Oct 17, 2001)
- K010466: Tether Acfs (May 16, 2001)
- K994382: Nonlinear Taper Lag Screw (Mar 10, 2000)
- K994383: Dogbone Acfs (Feb 4, 2000)

Source page: https://510kreport.com/company/theken-surgical