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Screw, Fixation, Intraosseous

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.4880
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.4880 Intraosseous fixation screw or wire

§ 872.4880 Intraosseous fixation screw or wire.

(a) Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

(b) Classification. Class II.

Screw, Fixation, Intraosseous

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.4880
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.4880 Intraosseous fixation screw or wire

§ 872.4880 Intraosseous fixation screw or wire.

(a) Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

(b) Classification. Class II.