Last synced on 25 November 2022 at 11:04 pm

Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material

Page Type
Product Code
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.3450
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.3450 Partial ossicular replacement prosthesis

§ 874.3450 Partial ossicular replacement prosthesis.

(a) Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

(b) Classification. Class II.

Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material

Page Type
Product Code
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.3450
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.3450 Partial ossicular replacement prosthesis

§ 874.3450 Partial ossicular replacement prosthesis.

(a) Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

(b) Classification. Class II.