# Osteotech, Inc.

- Location (FDA's records): Eatontown, NJ
- FDA decisions: 24 (1985–2008): 24 510(k) clearances
- Product codes: KWP (5), MQV (4), MBP (4), MQP (4), NUN (2), HWC (1), LRP (1), KIT (1), MNH (1), LYC (1)
- Predicates its devices cite: 23 (5 its own); citations of its devices by later devices: 50 (5 its own)
- Recalls linked to its devices: 34 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Exactech, Inc.: 4 (https://510kreport.com/company/exactech)
- Wrightmedicaltechnologyinc: 4 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Depuyacromed: 2 (https://510kreport.com/company/depuyacromed)
- Novabone Products, LLC: 2 (https://510kreport.com/company/novabone-products)
- Implex Corp.: 1 (https://510kreport.com/company/implex)
- Biocoll Laboratories, Inc.: 1 (https://510kreport.com/company/biocoll-laboratories)
- Bioform, Inc.: 1 (https://510kreport.com/company/bioform)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Firms that cite its devices most
- Medtronic Sofamor Danek: 9 (https://510kreport.com/company/medtronic-sofamor-danek)
- Nu Vasive, Incorporated: 3 (https://510kreport.com/company/nu-vasive)
- Ulrich GmbH & Co. KG: 3 (https://510kreport.com/company/ulrich)
- Novabone Products, LLC: 2 (https://510kreport.com/company/novabone-products)
- Ulrich Medical USA: 2 (https://510kreport.com/company/ulrich-medical-usa)
- K2m, Inc.: 2 (https://510kreport.com/company/k2m)
- Isotis Orthobiologics, Inc.: 2 (https://510kreport.com/company/isotis-orthobiologics)
- Theken Spine, LLC: 2 (https://510kreport.com/company/theken-spine)

## Its most-cited devices
- K012254: VBR (2001), cited by 18
- K051195: Grafton DBM (2005), cited by 11
- K003155: Vertebral Body Replacement (2001), cited by 7
- K051188: Grafton DBM (2006), cited by 5
- K082615: Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices (2008), cited by 3
- K955173: SSCS (Segmental Spinal Correction System) (1996), cited by 2

## Recent decisions
- K082615: Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone Void Filler Devices (Oct 16, 2008)
- K081227: Plexur M (Jul 22, 2008)
- K080511: Plexur-P (Apr 21, 2008)
- K073405: Plexur M (Mar 3, 2008)
- K061982: Plexur P (Feb 7, 2007)
- K051188: Grafton DBM (Jan 3, 2006)
- K051195: Grafton DBM (Dec 16, 2005)
- K051781: Graftcage TLX (Dec 16, 2005)

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