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510(k) K112983

SPACER-S by Tecres S.P.A. — Product Code HSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2011
Date Received
October 6, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class
Class II
Regulation Number
888.3690
Review Panel
OR
Submission Type

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  • K181732 — InterSpace Knee Extra-Large Size, InterSpace Knee ATS (April 27, 2019)
  • K122175 — MENDEC SPINE HV, MENDEC SPINE HV SYSTEM (March 28, 2013)
  • K101356 — Spacer-G and Spacer-K (September 20, 2011)
  • K092773 — CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST (November 24, 2009)
  • K062274 — SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221 (May 22, 2008)
  • K062273 — SPACER-G TEMPORARY HIP PROSTHESIS (May 22, 2008)
  • K063438 — VSPSPN (January 17, 2007)

Other clearances for product code HSD

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  • K221232 — Univers Revers Humeral Cup Implant (May 19, 2022)
  • K191433 — AGILON® XO Shoulder Replacement System (November 12, 2020)
  • K193122 — Biocore9 Humeral Resurfacing System (May 15, 2020)
  • K173964 — OVOMotion Shoulder Arthroplasty System (April 18, 2018)
  • K161782 — Arthrex Univers Revers Shoulder Prosthesis System (November 21, 2016)
  • K161620 — Anatomical Shoulder Domelock Dome centric (November 1, 2016)
  • K151527 — Arthrex Univers Revers CA Heads and Adapters (April 19, 2016)
  • K142942 — HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System (December 19, 2014)
  • K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (November 26, 2013)