Regen Collagen Scaffold (CS)
FDA 510(k) K082079 · Regen Biologics, Inc.
Submission
- Device name
- Regen Collagen Scaffold (CS)
- Applicant
- Regen Biologics, Inc.
Hackensack, NJ, US - Received
- July 23, 2008
- Decision date
- December 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLC – Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Intended for use in surgical procedures for the repair and reinforcement of soft tissue injuries of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site must extend at least into the red/white zone of the meniscus to provide…
Other 510(k)s with product code OLC
Questions and answers
When was Regen Collagen Scaffold (CS) cleared by the FDA?
Regen Collagen Scaffold (CS) (K082079) received a 510(k) decision of Substantially Equivalent on December 18, 2008, 148 days after the submission was received.
What is the product code of K082079?
The FDA product code is OLC – Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen, a Class II (moderate risk) device regulated under 21 CFR 878.3300.