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FDA 510(k)

SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]

K-Number: K951904 · 1995-07-17

ApplicantSynthes (Usa)
Decision Date1995-07-17
Product CodeJDO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1995-07-17 under 510(k) number K951904. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]?

SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] is a medical device that received FDA 510(k) clearance on 1995-07-17. The listed applicant is Synthes (Usa). The 510(k) number is K951904.

When did SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] receive FDA 510(k) clearance?

SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] received FDA 510(k) clearance on 1995-07-17, under 510(k) number K951904.

Who is the listed applicant for SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]?

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 (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]?

The FDA product code for SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] is JDO.

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Other records listing Synthes (Usa) as applicant

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Related Devices (Code: JDO)

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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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