TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT— 510(k) K121509
Substantially EquivalentTgm Medical, Inc.
FDA 510(k) clearance K121509 for TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT, Substantially Equivalent on 2012-11-05. Applicant: Tgm Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Tgm Medical, Inc.
- Product code
- Code KWY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3390
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- El Dorado, CA, US
Recent devices under product code KWY
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view all- K150576 — TGM Biolox delta Ceramic Heads
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- K121636 — ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT
- K112285 — MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE...
Adverse events under product code KWY
product code KWY- Death
- 3
- Injury
- 2,049
- Total
- 2,052
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.