LUBINUS SP II HIP SYSTEM— 510(k) K953653
Substantially EquivalentTurnkey Intergration USA, Inc.
FDA 510(k) clearance K953653 for LUBINUS SP II HIP SYSTEM, Substantially Equivalent on 1995-11-06. Applicant: Turnkey Intergration USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Turnkey Intergration USA, Inc.
- Product code
- Code JDG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code JDG
view allMore clearances from Turnkey Intergration USA, Inc.
view allAdverse events under product code JDG
product code JDG- Injury
- 804
- Malfunction
- 3,242
- Total
- 4,046
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 →
Recalls naming K953653
K-number listed on FDA's recall record- Z-2288-2025 — Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
- Z-1296-2024 — SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented
- Z-1297-2024 — SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
- Z-1298-2024 — SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
- Z-1299-2024 — SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K953653.
Data sourced from openFDA. This site is unofficial and independent of the FDA.