Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- ESFPolymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent2Product Code
- EZXMesh, Surgical, Metal2Product Code
- MIBElastomer, Silicone Block2Product Code
- MICImplant, Muscle, Pectoralis2Product Code
- BTXBoard, Arm (With Cover), Sterile1Product Code
- FTLMesh, Surgical, Polymeric2Product Code
- FTMMesh, Surgical2Product Code
- FTNPlastic Surgery And Accessories Kit1Product Code
- FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3Product Code
- FWMProsthesis, Breast, Inflatable, Internal, Saline3Product Code
- FWPProsthesis, Chin, Internal2Product Code
- FYIAppliance, Facial Fracture, External1Product Code
- FZDProsthesis, Ear, Internal2Product Code
- FZEProsthesis, Nose, Internal2Product Code
- FZFSplint, Extremity, Inflatable, External1Product Code
- GBIMaterial, External Aesthetic Restoration, Used With Adhesive1Product Code
- GBJProsthesis, Adhesive, External1Product Code
- JCQProsthesis, Esophagus2Product Code
- KCZProsthesis, Breast, External, Used With Adhesive1Product Code
- KDAProsthesis, Ptfe/Carbon-Fiber2Product Code
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2Product Code
- LZKImplant, Malar2Product Code
- K021419AART MALAR IMPLANT2Cleared 510(K)
- K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)2Cleared 510(K)
- K992240PILLAR MALAR IMPLANT2Cleared 510(K)
- K983756SURGIFORM ANATOMICAL MALAR2Cleared 510(K)
- K982763SEARE BIOMEDICAL MALAR IMPLANTS2Cleared 510(K)
- K981835SILIMED MALAR IMPLANT2Cleared 510(K)
- K980140SPECTRUM DESIGNS MEDIAL MALAR IMPLANT2Cleared 510(K)
- K980141SPECTRUM DESIGNS PROJECTION MALAR IMPLANT2Cleared 510(K)
- K980139SPECTRUM DESIGNS PROFILE MALAR IMPLANT2Cleared 510(K)
- K973502IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT2Cleared 510(K)
- K973574DURALASTIC ANATOMICAL MALAR IMPLANT2Cleared 510(K)
- K971479DURALASTIC ANATOMICAL MALAR IMPLANTS2Cleared 510(K)
- K970400BONE SOURCE HYDROXYAPATITE2Cleared 510(K)
- K964443SURGIFORM ANATOMICAL MALAR2Cleared 510(K)
- K962261IMPLANTECH WM NASAL-LABIAL IMPLANT2Cleared 510(K)
- K961511HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER2Cleared 510(K)
- K961210SAM FACIAL IMPLANT2Cleared 510(K)
- K961080MEDIAL MALAR IMPLANT2Cleared 510(K)
- K960354PERMAMESH-D HYDROXYLAPATITE MATRIX2Cleared 510(K)
- K960362PERMAMESH HYDROXYLAPATITE MATRIX2Cleared 510(K)
- K943988IMPLANTECH NASAL LABIAL IMPLANT2Cleared 510(K)
- K944166DORSAL COLUMELLA IMPLANT2Cleared 510(K)
- K944165SILHOUETTE MALAR IMPLANT2Cleared 510(K)
- K944164MENISCUS CHIN IMPLANT2Cleared 510(K)
- K942420IMPLANTECH MIDFACE-SUBMALAR LE FORT IMPLANT2Cleared 510(K)
- K942421IMPLANTECH LATERAL MANDIBULAR BAR IMPLANT2Cleared 510(K)
- K934233ZARA ZONE IV MALAR IMPLANT MODIFICATION2Cleared 510(K)
- K921582FLOWERS MEDIAL MALAR IMPLANT2Cleared 510(K)
- K914016ZARA ZONE IV MALAR IMPLANT2Cleared 510(K)
- K911515EXTENDED MALAR IMPLANT2Cleared 510(K)
- K911513TRAPEZOIDAL MALAR IMPLANT2Cleared 510(K)
- K910655COMBINED MALAR IMPLANT2Cleared 510(K)
- K904348CUI FEATHERED SILICONE MALAR2Cleared 510(K)
- K902284ZYMALAR IMPLANT2Cleared 510(K)
- K903329CUI ANATOMICAL SILICONE MALAR2Cleared 510(K)
- K901662ANATOMICAL MALAR IMPLANT2Cleared 510(K)
- K895152BINDER SUBMALAR FACIAL IMPLANT II2Cleared 510(K)
- K894493BINDER SUBMALAR FACIAL IMPLANT2Cleared 510(K)
- K873434CREAT BRAND MALAR IMPLANT2Cleared 510(K)
- K863400BYRON EXTENDED MALAR AND BYRON CONTOURED MALAR2Cleared 510(K)
- MCATape, Surgical, Internal2Product Code
- MNFImplant, Temporal2Product Code
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile1Product Code
- NODBoard, Arm (With Cover), Non-Sterile1Product Code
- NOJProsthesis, Breast, External, No Adhesive1Product Code
- NOKMaterial, External Aesthetic Restoration, No Adhesive1Product Code
- NWAProsthesis, Tracheal, Preformed/Molded2Product Code
- NYTProsthesis, Tracheal, Expandable, Polymeric2Product Code
- ODUFacial Implant2Product Code
- OXGMesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery2Product Code
- OODSurgical Film2Product Code
- OQLMesh, Surgical, Deployment Balloon2Product Code
- ORQMesh, Surgical, Deployer2Product Code
- OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery2Product Code
- OWSMesh, Surgical, Collagen, Plastics, Facial Implants2Product Code
- OWTMesh, Surgical, Absorbable, Abdominal Hernia2Product Code
- OWUMesh, Surgical, Non-Absorbable, Diaphragmatic Hernia2Product Code
- OWVMesh, Surgical, Collagen, Diaphragmatic Hernia2Product Code
- OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXAMesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction2Product Code
- OXCMesh, Surgical, Absorbable, Staple Line Reinforcement2Product Code
- OXDMesh, Surgical, Non-Absorbable, Staple Line Reinforcement2Product Code
- OXEMesh, Surgical, Collagen, Staple Line Reinforcement2Product Code
- OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery2Product Code
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery2Product Code
- OXIMesh, Surgical, Absorbable, Large Abdominal Wall Defects2Product Code
- OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects2Product Code
- OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects2Product Code
- OXLMesh, Surgical, Absorbable, Organ Support2Product Code
- OXMMesh, Surgical, Absorbable, Fistula2Product Code
- OXNMesh, Surgical, Collagen, Fistula2Product Code
- PIJCollagen Surgical Mesh Containing Drugs2Product Code
- PQNCarbon Dioxide Gas Controlled Tissue Expander2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BONE SOURCE HYDROXYAPATITE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K970400
- 510(k) Type
- Traditional
- Applicant
- Orthofix, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/2/1997
- Days to Decision
- 88 days
- Submission Type
- Summary