# Tecres S.P.A.

- Location (FDA's records): Rockville, MD
- FDA decisions: 15 (2004–2025): 15 510(k) clearances
- Names in FDA's records: Tecres S.P.A. (14); Tecres (1)
- Product codes: NDN (5), KWL (3), JWH (2), LOD (2), HSD (2), GXP (1)
- Predicates its devices cite: 35 (9 its own); citations of its devices by later devices: 25 (9 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
- Exactech, Inc.: 7 (https://510kreport.com/company/exactech)
- Medtronic, Inc.: 5 (https://510kreport.com/company/medtronic)
- Biomet, Inc.: 3 (https://510kreport.com/company/biomet)
- Kyphon, Inc.: 3 (https://510kreport.com/company/kyphon)
- Cossington, Ltd.: 2 (https://510kreport.com/company/cossington)
- Stryker Corp.: 2 (https://510kreport.com/company/stryker)
- Osteoremedies, LLC: 1 (https://510kreport.com/company/osteoremedies)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)

## Firms that cite its devices most
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Osteoremedies, LLC: 2 (https://510kreport.com/company/osteoremedies)
- G21, S.R.L.: 2 (https://510kreport.com/company/g21)
- Cossington, Ltd.: 1 (https://510kreport.com/company/cossington)
- Osartis GmbH: 1 (https://510kreport.com/company/osartis)
- Teknimed, S.A.: 1 (https://510kreport.com/company/teknimed)
- Spineart: 1 (https://510kreport.com/company/spineart)
- Heraeus Medical GmbH: 1 (https://510kreport.com/company/heraeus-medical)

## Its most-cited devices
- K042415: Mendec Spine (2005), cited by 5
- K112983: Spacer-S (2011), cited by 4
- K062274: Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321 (2008), cited by 3
- K101356: Spacer-G and Spacer-K (2011), cited by 3
- K062452: Kit Mendec Spine and Delivery System (2006), cited by 2
- K060535: Spacer-S Temporary Shoulder Spacer (2006), cited by 2

## Recent decisions
- K252326: InterSpace GV Hip Spacer (Aug 6, 2025)
- K211163: Bone Cement Genta, Bone Cement HV, Bone Cement LV (Jan 9, 2023)
- K220131: KYPHON VuE Bone Cement (Apr 18, 2022)
- K181732: InterSpace Knee Extra-Large Size, InterSpace Knee ATS (Apr 27, 2019)
- K122175: Mendec Spine HV, Mendec Spine HV System (Mar 28, 2013)
- K112983: Spacer-S (Dec 12, 2011)
- K101356: Spacer-G and Spacer-K (Sep 20, 2011)
- K092773: Cemex Genta, Genta System and Genta System Fast (Nov 24, 2009)

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