PriMatrix Dermal Repair Scaffold— 510(k) K153690
Substantially EquivalentTei Biosciences, Inc.
FDA 510(k) clearance K153690 for PriMatrix Dermal Repair Scaffold, Substantially Equivalent on 2016-02-22. Applicant: Tei Biosciences, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Tei Biosciences, Inc.
- Product code
- Code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MD, US
Recent devices under product code KGN
view allMore clearances from Tei Biosciences, Inc.
view allAdverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K153690
K-number listed on FDA's recall record- Z-2077-2023 — PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
- Z-2078-2023 — PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
- Z-2079-2023 — PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
- Z-0383-2018 — PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153690.
Data sourced from openFDA. This site is unofficial and independent of the FDA.