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Device
filler, bone void, calcium compound
Regulation Description
Resorbable calcium salt bone void filler device.
Regulation Medical Specialty
Orthopedic
Review Panel
Orthopedic
Product Code
MQV
Premarket Review
Restorative, Repair and Trauma Devices
(DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type
510(k)
Regulation Number
888.3045
Device Class
2
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Eligible
Implanted Device?
Yes
Life-Sustain/Support Device?
No
Recognized Consensus Standards
8-427 ASTM F1185-03 (Reapproved 2014)
Standard Specification for Composition of Hydroxylapatite for Surgical Implants
8-429 ASTM F2224-09 (Reapproved 2020)
Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
8-457 ISO 13175-3 First edition 2012-10-01
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
8-491 ASTM F1088-18
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
8-493 ISO 13779-2 Third edition 2018-12
Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite
8-516 ISO 13779-4 Second edition 2018-12
Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength
8-579 ISO 13779-3 Second Edition 2018-12
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)]
8-593 ISO 13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15
Implants for surgery - Hydroxyapatite - Part 6: Powders
11-197 ASTM F983-86 (Reapproved 2018)
Standard Practice for Permanent Marking of Orthopaedic Implant Components
11-199 ASTM F565-04 (Reapproved 2018)
Standard Practice for Care and Handling of Orthopedic Implants and Instruments
15-44 ASTM F2529-13
Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
15-54 ASTM F3207-17
Standard Guide for in vivo Evaluation of Rabbit Lumbar Intertransverse Process Spinal Fusion Model
Guidance Document
Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA
Third Party Review
Not Third Party Eligible
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