WRISTORE FIXATOR— 510(k) K012294
Substantially EquivalentMillennium Medical Technologies, Inc.
FDA 510(k) clearance K012294 for WRISTORE FIXATOR, Substantially Equivalent on 2002-03-04. Applicant: Millennium Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Millennium Medical Technologies, Inc.
- Product code
- Code KTT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasant Hill, CA, US
Recent devices under product code KTT
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view all- K170449 — Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection
- K081039 — LIPO CANNULA
- K031050 — PCW PERCUTANEOUS COMPRESSION WIRE
- K020791 — HBS HEADLESS BONE SCREW
Adverse events under product code KTT
product code KTT- Death
- 11
- Injury
- 3,097
- Malfunction
- 1,261
- Total
- 4,369
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.