Day Staple
by Protek, Inc.
510(k) K853267
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK853267 | Date6 Sep 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Overview
AI-generated summary, 26 Sep 2026
The Day Staple is a bone fixation staple used in orthopedic procedures. It is designed to provide stabilization and fixation for bone segments.
This device is classified as an FDA class 2 medical device under regulation 888.3030. It received FDA 510(k) clearance on September 6, 1985, under the K853267 submission.
Other devices from Protek, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the primary clinical use of the Day Staple?
The Day Staple is indicated for use in orthopedic procedures to provide stabilization and fixation for bone segments, helping to maintain the alignment of bone during the healing process.
What is the regulatory status of this device?
The Day Staple is classified as an FDA class 2 medical device under regulation 888.3030. It received FDA 510(k) clearance on September 6, 1985, under submission number K853267.
Who is the manufacturer of the Day Staple?
The Day Staple is manufactured by Protek, Inc., which is based in Indianapolis, Indiana.