FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
K Number: K020221
·
Decision Apr 2, 2002
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
34
Review Days
70
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Basic Information
- Device Name
- IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET
- K Number
- K020221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Orthopedics, Inc.
- Date Received
- January 22, 2002
- Decision Date
- April 2, 2002
- Product Code
- HRS
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
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Other Clearances by Biomet Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080528 | E-POLY TIBIAL BEARINGS | Jun 17, 2008 | Substantially Equivalent |
| K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | Jan 14, 2008 | Substantially Equivalent |
| K070955 | ACID ETCHED LAG SCREWS | Oct 12, 2007 | Substantially Equivalent |
| K033355 | LACTOSCREW SCREW ANCHOR | Jun 30, 2004 | Substantially Equivalent |
| K032286 | CALCIGEN PSI BONE GRAFT SUBSTITUTE | Nov 20, 2003 | Substantially Equivalent |
| K030048 | HA PMI FEMORAL HIP STEM | Feb 5, 2003 | Substantially Equivalent |
| K024086 | PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM | Jan 9, 2003 | Substantially Equivalent |
| K023063 | COMPREHENSIVE HUMERAL FRACTURE SYSTEM | Dec 13, 2002 | Substantially Equivalent |
| K023188 | PRESS-FIT HEAD RESURFACING DEVICE | Dec 11, 2002 | Substantially Equivalent |
| K023357 | ARCPM 1050 RESIN-HIPS | Nov 6, 2002 | Substantially Equivalent |