Rti Biologics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Rti Biologics, Inc. makes
Rti Biologics, Inc. produces porcine-derived dermal substitutes, including the FORTIVA PORCINE DERMIS for tissue regeneration, and a range of Tutopatch and Tutomesh models designed for wound coverage and soft tissue repair. These products are processed biological tissues intended for surgical applications in reconstructive and plastic surgery.
The company’s portfolio is regulated under FDA Class II devices, with each product authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Fortiva Porcine Dermis Ref K123356
Regimes: 510(k) Registry: 510(k)Tutopatch, Tutomesh, Models 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 Ref K091142
Regimes: 510(k) Registry: 510(k)Tutopatch, Tutomesh Ref K081538
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Rti Biologics, Inc., initiated on 2011-04-09. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 9 Apr 2011 Z-2634-2011 Unclassified (pre-2012) Terminated RTI Biologics issued a recall of Osteofil DBM Paste, 5cc that was distributed on 03/04/2008 to one customer. The product was labeled as 5.0cc but should have been labeled as 0.5cc. All customers were notified of this recall on 04/09/2011.
Frequently asked questions
How many devices does Rti Biologics, Inc. have in the registry?
The registry currently lists 3 devices for Rti Biologics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rti Biologics, Inc.'s devices?
Among its 3 most recently registered devices, Rti Biologics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Rti Biologics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Rti Biologics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Rti Biologics, Inc.?
FDA recall records list 1 recall initiated by Rti Biologics, Inc., the most recent initiated on 9 Apr 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Rti Biologics, Inc. in the registry?
The most recently registered devices listed for Rti Biologics, Inc. include FORTIVA PORCINE DERMIS, TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358 and TUTOPATCH, TUTOMESH.