SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM— 510(k) K950099

Name: FDA 510(k) clearance K950099
Creator: U.S. Food and Drug Administration
Published: 1997-01-16

Substantially Equivalent for Some Indications

Buckman Co., Inc.

FDA 510(k) clearance K950099 for SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM, Substantially Equivalent for Some Indications on 1997-01-16. Applicant: Buckman Co., Inc.. Device class: 2.

Clearance details

Applicant: Buckman Co., Inc.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1995-01-10
Decision date: 1997-01-16
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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K964252 — ORTHOCHUCK1997-05-27
K960451 — WEBB-MORLEY SPINE SYSTEM1996-04-18
K950999 — KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS1996-01-25

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.