21 CFR 878.3910 — Board, Arm (With Cover), Sterile
General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3910
Identification
A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BTX | Board, Arm (With Cover), Sterile | 1 | 13 | |
| FYH | Splint, Extremity, Noninflatable, External, Sterile | 1 | 8 | |
| NOC | Splint, Extremity, Non-Inflatable, External, Non-Sterile | 1 | 0 | |
| NOD | Board, Arm (With Cover), Non-Sterile | 1 | 0 |
