# Custom Spine, Inc.

- Location (FDA's records): Parsippany, NJ
- FDA decisions: 14 (2005–2015): 14 510(k) clearances
- Names in FDA's records: Custom Spine, Inc. (12); Custom Spine (2)
- Product codes: MAX (5), KWP (2), NKB (2), KWQ (2), OVD (1), MRW (1), ODP (1)
- Predicates its devices cite: 42 (10 its own); citations of its devices by later devices: 34 (10 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
- Depuy, Inc.: 8 (https://510kreport.com/company/depuy)
- Depuyacromed: 6 (https://510kreport.com/company/depuyacromed)
- Spinal Elements, Inc.: 3 (https://510kreport.com/company/spinal-elements)
- X-Spine Systems, Inc.: 3 (https://510kreport.com/company/x-spine-systems)
- U&I Corp., America: 2 (https://510kreport.com/company/u-i-america)
- Depuy Motech Acromed: 2 (https://510kreport.com/company/depuy-motech-acromed)
- Spinal USA: 2 (https://510kreport.com/company/spinal-usa)
- Vertebration,Inc: 1 (https://510kreport.com/company/vertebration)

## Firms that cite its devices most
- Cumtom Spine: 4 (https://510kreport.com/company/cumtom-spine)
- Life Spine, Inc.: 2 (https://510kreport.com/company/life-spine)
- Amendia, Inc.: 2 (https://510kreport.com/company/amendia)
- Axis Spine Technologies, Ltd.: 2 (https://510kreport.com/company/axis-spine-technologies)
- Keos: 1 (https://510kreport.com/company/keos)
- Alliance Partners, LLC: 1 (https://510kreport.com/company/alliance-partners)
- Cogent Spine, LLC: 1 (https://510kreport.com/company/cogent-spine)
- Globus Medical, Inc.: 1 (https://510kreport.com/company/globus-medical)

## Its most-cited devices
- K090566: Pathway Avid (2009), cited by 7
- K070281: Issys LP Spinal Fixation System (2007), cited by 4
- K132596: Proposed Optimus (2014), cited by 4
- K043522: Issys Pedicle Screw System (2005), cited by 3
- K092904: Pathway Ivb/VBR (2009), cited by 3
- K080281: Pathway (2008), cited by 3

## Recent decisions
- K143143: Pathway Elif (Jul 22, 2015)
- K132596: Proposed Optimus (Apr 11, 2014)
- K120597: Kompreda (May 3, 2013)
- K111726: Pathway Avid (Feb 6, 2012)
- K111774: Pathway Model 07XXXX (Jul 20, 2011)
- K111099: Issys LP Spinal Fixation System (May 5, 2011)
- K101151: Regent Anterior Cervical Plate (May 19, 2010)
- K092904: Pathway Ivb/VBR (Dec 22, 2009)

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