Atlas FDA

SHEA LOCKING BAIL PROSTHESIS

FDA 510(k) clearance K802873 · decided 1980-12-19

Clearance details

K-number
K802873
Device name
SHEA LOCKING BAIL PROSTHESIS
Applicant
Richard'S Medical Equip., Inc.
Decision
Substantially Equivalent
Date received
1980-11-14
Decision date
1980-12-19
Days to decision
35 days
Clearance type
Traditional
Product code
ETB
Device class
2
Regulation number
874.3450
Medical specialty
Ear, Nose, Throat
Advisory committee
Ear, Nose, Throat
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); (K260720)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit (K241261)MED-EL Elektromedizinische Geräte GmbH2025-01-17
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NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS (K130512)Heinz Kurz GmbH Medizintechnik2013-12-02
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GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES (K061853)Grace Medical, Inc.2006-08-18
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Recalls involving this device

No recalls on record reference this clearance.