BONE-LOK HP WASHER— 510(k) K040250
Substantially EquivalentTriage Medical, Inc.
FDA 510(k) clearance K040250 for BONE-LOK HP WASHER, Substantially Equivalent on 2004-03-23. Applicant: Triage Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Triage Medical, Inc.
- Product code
- Code HTN
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code HTN
view allMore clearances from Triage Medical, Inc.
view all- K062391 — DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00
- K052043 — 3.8MM CS FACET COMPRESSION DEVICE
- K051949 — 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
- K043351 — 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N
- K042244 — BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
Adverse events under product code HTN
product code HTN- Injury
- 310
- Malfunction
- 639
- Total
- 949
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.