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510(k) K172573

ReBOSSIS85 by Orthorebirth Co., Ltd. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2017
Date Received
August 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Orthorebirth Co., Ltd.

  • K240453 — ReBOSSIS (March 4, 2024)
  • K170620 — ReBOSSIS85 (June 23, 2017)
  • K142090 — REBOSSIS (October 29, 2014)

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