CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON— 510(k) K072327
Substantially EquivalentRegeneration Technologies, Inc.
FDA 510(k) clearance K072327 for CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON, Substantially Equivalent on 2007-10-24. 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
- Special
- Location
- Alachua, FL, US
Recent devices under product code MQV
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- K072238 — BIOSET XCH
- K063584 — STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937
- K060180 — BIOSET XC
- K060253 — STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST.
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.