FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
K Number: K040022
·
Decision Mar 12, 2004
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
12
Review Days
65
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Basic Information
- Device Name
- STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
- K Number
- K040022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Leibinger
- Date Received
- January 7, 2004
- Decision Date
- March 12, 2004
- 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 Stryker Leibinger
| K Number | Device Name | ||
|---|---|---|---|
| K052871 | STRYKER CUSTOM TI IMPLANT | Dec 16, 2005 | Substantially Equivalent |
| K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | Apr 15, 2005 | Substantially Equivalent |
| K041651 | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM | Sep 30, 2004 | Substantially Equivalent |
| K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | Jun 2, 2003 | Substantially Equivalent |
| K023449 | NON-INVASIVE PATIENT FIXATION SYSTEM | Jan 13, 2003 | Substantially Equivalent |
| K013775 | TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM | Jan 8, 2002 | Substantially Equivalent |
| K012380 | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY | Dec 3, 2001 | Substantially Equivalent |
| K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE | Dec 8, 2000 | Substantially Equivalent |
| K000349 | MOTORIZED MICRO MULTILEAF COLLIMATOR | May 3, 2000 | Substantially Equivalent |
| K000348 | COLORADO MICRODISSECTION NEEDLE | May 3, 2000 | Substantially Equivalent |