PARTIAL OSSICULAR REPLACEMENT PROSTHESES— 510(k) K060518
Substantially EquivalentGrace Medical, Inc.
FDA 510(k) clearance K060518 for PARTIAL OSSICULAR REPLACEMENT PROSTHESES, Substantially Equivalent on 2006-06-28. Applicant: Grace Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Grace 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
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- K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
More clearances from Grace Medical, Inc.
view allRecalls naming K060518
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060518.
Data sourced from openFDA. This site is unofficial and independent of the FDA.