Suface Replacement Elbow
510(k) K820957
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820957 | Date2 Jul 1982 | 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- Withdrawn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
- JDB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3160
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Surface Replacement Elbow is a semi-constrained, cemented elbow prosthesis. It is designed to replace the elbow joint as a medical implant.
This device is manufactured by Howmedica Corp. and has received FDA 510(k) clearance under K820957. It is classified as a Class II medical device under regulation number 888.3160.
Other devices from Howmedica Corp.
Questions
AI-generated answers, 24 Sep 2026
What is the Surface Replacement Elbow used for?
This device is a semi-constrained, cemented elbow prosthesis intended to replace the elbow joint as a medical implant.
What is the regulatory status of this device?
The Surface Replacement Elbow has received FDA 510(k) clearance under number K820957. It is classified as a Class II medical device under regulation number 888.3160.
Who is the manufacturer of this elbow prosthesis?
The device is manufactured by Howmedica Corp., located in McHenry, Illinois.