510(k) clearances

Moldable Bone Void Filler and Moldable Bone Void Filler + CCC

Rti Surgical, Inc. · Orthopedic

K241555Substantially EquivalentTraditionalMQV
Open FDA's page for this record
Third party flag
N
City
Alachua
Advisory committee description
Orthopedic
Address 1
11621 Research Cir.
Statement or summary
Summary
Product code
MQV
Zip code
32615
Applicant
Rti Surgical, Inc.
Decision date
2025-02-21
Decision code
SESE
Country code
US
Device name
Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
Advisory committee
OR
Contact
Ellen Rounds
K number
K241555
State
FL
Date received
2024-05-31
Review advisory committee
OR
Postal code
32615
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Filler, Bone Void, Calcium Compound
Medical specialty description
Orthopedic
Regulation number
888.3045
Device class
2
Registration number
3019403037, 3011964577, 9610612, 3011662387, 3005064037, 3018094310, 1720734, 3008868758, 3010376334, 8043792, 3005972619, 3006788678, 1226544, 3008514120, 3005381997, 3003828812, 3005180920, 1645368, 2530154, 3015219237, 3002636527, 3030412764, 3027448274, 3013497559, 3008114965, 3003477135, 3008328709, 3004111573, 2030598, 3013820501, 2953359, 3033509898, 3008812560, 3006017180, 3012329552, 3011415547, 3011121816, 3006404071, 3002807310, 2246552 +186 more
FEI number
3019403037, 3011964577, 3011662387, 3005064037, 3018094310, 1720734, 1000477302, 3008868758, 3005972619, 3006788678, 3000303710, 3008514120, 3005381997, 3003828812, 3005180920, 3002808269, 3006813973, 3002807172, 3015219237, 3003414678, 3002807091, 3003015552, 3030412764, 3027448274, 3002636527, 3013497559, 3008114965, 3003477135, 3008328709, 3004111573, 3013820501, 3033509898, 3002924544, 3008812560, 3006017180, 3012329552, 3011415547, 3011121816, 3006404071, 3002807310 +186 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.