510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082079Substantially Equivalent

Regen Collagen Scaffold (Cs)

Regen Biologics, Inc., Hackensack NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082079 is the FDA 510(k) clearance record for REGEN COLLAGEN SCAFFOLD (CS), a class II device, cleared for Regen Biologics, Inc. on under FDA product code OLC (Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen). FDA's definition for product code OLC reads: "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...". FDA records list one 510(k) clearance for Regen Biologics, Inc. As of , FDA records show no recalls naming K082079.

Clearance record

Decision date
Received
(148 days to decision)
Product code
OLC Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Regen Biologics, Inc. 411 Hackensack Ave., Hackensack NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLC

Trailing 12 months

FDA records hold no clearances under product code OLC in the trailing twelve months.

FDA records show no clearances under product code OLC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OLC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260