PBP TOTAL HIP SYSTEM— 510(k) K122158
Substantially EquivalentPipeline Biomedical Products, LLC
FDA 510(k) clearance K122158 for PBP TOTAL HIP SYSTEM, Substantially Equivalent on 2012-12-11. Applicant: Pipeline Biomedical Products, LLC. Device class: 2.
Clearance details
- Applicant
- Pipeline Biomedical Products, LLC
- Product code
- Code OQG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alexandria, VA, US
Recent devices under product code OQG
view all- K202705 — Prime and DYNASTY® Additive Manufacturing Shells
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- K200328 — Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
- K172651 — FMP Extended Liners
Adverse events under product code OQG
product code OQG- Injury
- 249
- Total
- 249
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.