OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC— 510(k) K043421
Substantially EquivalentRegeneration Technologies, Inc.
FDA 510(k) clearance K043421 for OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC, Substantially Equivalent on 2005-02-16. Applicant: Regeneration Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Regeneration Technologies, Inc.
- Product code
- Code MQV
- Device class
- Class 2
- Regulation
- 21 CFR 888.3045
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alachua, FL, US
Recent devices under product code MQV
view allMore clearances from Regeneration Technologies, Inc.
view all- K080418 — REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
- K072238 — BIOSET XCH
- K072327 — CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
- K063584 — STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937
- K060180 — BIOSET XC
Adverse events under product code MQV
product code MQV- Death
- 6
- Injury
- 435
- Total
- 441
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 K043421
K-number listed on FDA's recall record- Z-1688-2019 — Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
- Z-1689-2019 — Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
- Z-1690-2019 — Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
- Z-1441-2017 — RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications
- Z-0939-2014 — ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043421.
Data sourced from openFDA. This site is unofficial and independent of the FDA.