FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURFACE REPLACEMENT HIP PROSTHESIS
K Number: K811718
·
Decision Sep 18, 1981
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
38
Applicant Total
441
Review Days
92
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
- SURFACE REPLACEMENT HIP PROSTHESIS
- K Number
- K811718
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Biomet, Inc.
- Date Received
- June 18, 1981
- Decision Date
- September 18, 1981
- Product Code
- KYB
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYB), ordered by most recent decision date.
MicroSTAAR Injector System Cartridges
FDA 510(k)
FDA Class 1
·Ophthalmic
DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
FDA 510(k)
FDA Class 1
·Ophthalmic
DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2
FDA 510(k)
FDA Class 1
·Ophthalmic
IOL INJECTOR SET
FDA 510(k)
FDA Class 1
·Ophthalmic
MONARCH III IOL DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·Ophthalmic
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28
FDA 510(k)
FDA Class 1
·Ophthalmic
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 |