FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CRUCIATE LIGAMENT BUTTON
K Number: K813581
·
Decision Mar 23, 1982
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
19
Applicant Total
441
Review Days
85
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CRUCIATE LIGAMENT BUTTON
- K Number
- K813581
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4930
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Biomet, Inc.
- Date Received
- December 28, 1981
- Decision Date
- March 23, 1982
- Product Code
- KGS
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGS | Retention Device, Suture | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGS), ordered by most recent decision date.
SOFT TISSUE ANCHORING WASHERS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RBM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SUTURE LOCK
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACUFEX ROTATOR CUFF FIXATION BUTTON
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MITEK CONE WASHER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VENTROFIL TENSION RELIEF SUTURE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Biomet, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251270 | Taperloc® Complete Hip Stem | May 19, 2026 | Substantially Equivalent |
| K241014 | Biomet Kirschner Wires (K-Wires) | May 22, 2024 | Substantially Equivalent |
| K222760 | StageOne Select Hip Cement Spacer Molds | Dec 28, 2022 | Substantially Equivalent |
| K221968 | StageOne Shoulder Cement Spacer Molds | Sep 15, 2022 | Substantially Equivalent |
| K213287 | StageOne Knee Cement Spacer Molds | Sep 2, 2022 | Substantially Equivalent |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | Feb 7, 2022 | Substantially Equivalent |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | Dec 10, 2021 | Substantially Equivalent |
| K210192 | A.L.P.S. Clavicle Plating System | Feb 19, 2021 | Substantially Equivalent |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws | Nov 10, 2020 | Substantially Equivalent |
| K193546 | Distal Centralizers | Sep 25, 2020 | Substantially Equivalent |