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FDA 510(k)

SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS

K-Number: K033868 · 2004-06-21

ApplicantSynthes (Usa)
Decision Date2004-06-21
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2004-06-21 under 510(k) number K033868. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS?

SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS is a medical device that received FDA 510(k) clearance on 2004-06-21. The listed applicant is Synthes (Usa). The 510(k) number is K033868.

When did SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS receive FDA 510(k) clearance?

SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS received FDA 510(k) clearance on 2004-06-21, under 510(k) number K033868.

Who is the listed applicant for SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS?

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) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS?

The FDA product code for SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS is GXN.

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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: GXN)

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.

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)Longeviti Neuro SolutionsK2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.K243715Synthes Patient Specific ImplantsSynthes GmbHK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEKLS-Martin L.P.

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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