# Tei Biosciences, Inc.

- Location (FDA's records): Boston, MA
- FDA decisions: 16 (2002–2017): 16 510(k) clearances
- Product codes: FTM (7), KGN (5), FTL (2), PAJ (1), FRO (1)
- Predicates its devices cite: 30 (18 its own); citations of its devices by later devices: 34 (18 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook Biotech, Inc.: 4 (https://510kreport.com/company/cook-biotech)
- Organogenesis, Inc.: 2 (https://510kreport.com/company/organogenesis)
- Tissue Science Laboratories, Plc: 2 (https://510kreport.com/company/tissue-science-laboratories)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)
- Johnson & Johnson Medical, Inc.: 1 (https://510kreport.com/company/johnson-johnson-medical)
- Covalontechnologies, Inc.: 1 (https://510kreport.com/company/covalontechnologies)
- Exciton Technologies, Inc.: 1 (https://510kreport.com/company/exciton-technologies)

## Firms that cite its devices most
- Brennen Medical, Inc.: 2 (https://510kreport.com/company/brennen-medical)
- Regen Biologics, Inc.: 2 (https://510kreport.com/company/regen-biologics)
- Integra Lifesciences Corporation (Owner of Tei Biosciences): 1 (https://510kreport.com/company/integra-lifesciences-owner-of-tei-biosciences)
- Sewon Cellontech Co., Ltd.: 1 (https://510kreport.com/company/sewon-cellontech)
- Marine Polymer Technologies, Inc.: 1 (https://510kreport.com/company/marine-polymer-technologies)
- Cormatrix Cardiovascular, Inc.: 1 (https://510kreport.com/company/cormatrix-cardiovascular)
- Aroa Biosurgery, Ltd.: 1 (https://510kreport.com/company/aroa-biosurgery)
- Mast Biosurgery USA, Inc.: 1 (https://510kreport.com/company/mast-biosurgery-usa)

## Its most-cited devices
- K020455: Tissuemend Soft Tissue Repair Matrix (2002), cited by 5
- K083898: Surgimend (2009), cited by 4
- K023778: Dressskin (2003), cited by 4
- K083440: Primatrix Dermal Repair Scaffold (2008), cited by 4
- K051766: Orthomend (2005), cited by 3
- K031188: Orthomend (2003), cited by 2

## Recent decisions
- K162965: SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction (Feb 16, 2017)
- K153690: PriMatrix Dermal Repair Scaffold (Feb 22, 2016)
- K131286: Primatrix Dermal Repair Scaffold (Aug 5, 2013)
- K100261: Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold (Dec 10, 2010)
- K083898: Surgimend (Feb 4, 2009)
- K083440: Primatrix Dermal Repair Scaffold (Dec 12, 2008)
- K071807: Orthomend Soft Tissue Matrix (Aug 6, 2007)
- K061407: Primatrix Dermal Repair Scaffold (Jun 29, 2006)

Source page: https://510kreport.com/company/tei-biosciences