BUCKET PROSTHESIS PORP— 510(k) K883727
Substantially EquivalentTreace Medical, Inc.
FDA 510(k) clearance K883727 for BUCKET PROSTHESIS PORP, Substantially Equivalent on 1989-01-13. Applicant: Treace Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Treace Medical, Inc.
- Product code
- Code ETB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3450
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Recent devices under product code ETB
view all- K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669) +10 more
- K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more
- K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
- K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
- K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
More clearances from Treace Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.