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FDA 510(k)

SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)

K-Number: K002362 · 2000-11-01

ApplicantSynthes (Usa)
Decision Date2000-11-01
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2000-11-01 under 510(k) number K002362. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)?

SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) is a medical device that received FDA 510(k) clearance on 2000-11-01. The listed applicant is Synthes (Usa). The 510(k) number is K002362.

When did SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) receive FDA 510(k) clearance?

SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) received FDA 510(k) clearance on 2000-11-01, under 510(k) number K002362.

Who is the listed applicant for SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)?

The FDA 510(k) record lists Synthes (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)?

The FDA product code for SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) is MQV.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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