BIOSTOP G BONE CEMENT RESTRICTOR— 510(k) K943727

Substantially Equivalent

Landos, Inc.

FDA 510(k) clearance K943727 for BIOSTOP G BONE CEMENT RESTRICTOR, Substantially Equivalent on 1995-05-11. Applicant: Landos, Inc.. Device class: 2.

Clearance details

Applicant: Landos, Inc.
Product code: Code LZN
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1994-08-02
Decision date: 1995-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Landos, Inc.

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K961732 — KAR1997-07-08

Recalls naming K943727

K-number listed on FDA's recall record

Z-0951-2023 — BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)Class II·Ongoing·Depuy Ireland UC·20221219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K943727.

Data sourced from openFDA. This site is unofficial and independent of the FDA.