# Theken Spine, LLC

- Location (FDA's records): Akron, OH
- FDA decisions: 23 (2007–2012): 23 510(k) clearances
- Product codes: NKB (6), OVD (3), MQP (3), KWP (2), MAX (2), KWQ (2), MNI (2), ODP (1), HRX (1), OVE (1)
- Predicates its devices cite: 61 (17 its own); citations of its devices by later devices: 68 (17 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Theken Surgical,Llc: 14 (https://510kreport.com/company/theken-surgical)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Depuyacromed: 2 (https://510kreport.com/company/depuyacromed)
- Spinal Elements, Inc.: 2 (https://510kreport.com/company/spinal-elements)
- Osteotech, Inc.: 2 (https://510kreport.com/company/osteotech)
- Synthes Spine: 2 (https://510kreport.com/company/synthes-spine)
- Seaspine, Inc.: 1 (https://510kreport.com/company/seaspine)

## Firms that cite its devices most
- SeaSpine Orthopedics Corporation: 15 (https://510kreport.com/company/seaspine-orthopedics)
- Life Spine, Inc.: 6 (https://510kreport.com/company/life-spine)
- Centinel Spine, Inc.: 2 (https://510kreport.com/company/centinel-spine)
- Medacta International S.A.: 2 (https://510kreport.com/company/medacta-international)
- Spineart: 2 (https://510kreport.com/company/spineart)
- K2m, Inc.: 2 (https://510kreport.com/company/k2m)
- Aegis Spine, Inc.: 2 (https://510kreport.com/company/aegis-spine)
- Innovasis, Inc.: 1 (https://510kreport.com/company/innovasis)

## Its most-cited devices
- K101310: VU Apod Intervertebral Body Fusion Device (2010), cited by 11
- K080822: VU Apod Intervertabral Body Fusion Device (2008), cited by 9
- K070638: Theken Atoll Cervico-Thoracic System (2007), cited by 6
- K121211: VU Apod Intervertebral Body Fusion Device (2012), cited by 6
- K070962: Coral Pedicle Screw System (2007), cited by 6
- K083863: Theken Atoll Oct Spinal System (2009), cited by 5

## Recent decisions
- K121482: Instrument System for Endoscopic Spinal Surgery (Aug 28, 2012)
- K121211: VU Apod Intervertebral Body Fusion Device (Jun 27, 2012)
- K120829: Stainless Steel Spinal System (May 30, 2012)
- K120047: Coral Spinal System (Feb 3, 2012)
- K111675: VU C*Pod Intervertebral Body Fusion Device (Aug 2, 2011)
- K103228: Paramount R Ibf Device (Jan 5, 2011)
- K102323: Cervical Standalone Intervertebral Body Fusion Device (Dec 16, 2010)
- K101310: VU Apod Intervertebral Body Fusion Device (Sep 2, 2010)

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