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FDA 510(k)

SYNTHES (USA) 2.0MM TITANIUM T-PLATE

K-Number: K072758 · 2007-12-18

ApplicantSynthes (Usa)
Decision Date2007-12-18
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) 2.0MM TITANIUM T-PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2007-12-18 under 510(k) number K072758. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) 2.0MM TITANIUM T-PLATE?

SYNTHES (USA) 2.0MM TITANIUM T-PLATE is a medical device that received FDA 510(k) clearance on 2007-12-18. The listed applicant is Synthes (Usa). The 510(k) number is K072758.

When did SYNTHES (USA) 2.0MM TITANIUM T-PLATE receive FDA 510(k) clearance?

SYNTHES (USA) 2.0MM TITANIUM T-PLATE received FDA 510(k) clearance on 2007-12-18, under 510(k) number K072758.

Who is the listed applicant for SYNTHES (USA) 2.0MM TITANIUM T-PLATE?

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) 2.0MM TITANIUM T-PLATE?

The FDA product code for SYNTHES (USA) 2.0MM TITANIUM T-PLATE is GWO.

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Other records listing Synthes (Usa) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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Related Devices (Code: GWO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262874CraniUS PlateCraniUS, LLCK261058CraniUS PlateCraniUS, LLCK250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, Inc.

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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