FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASTERPIECES(TM)/MICRO/MINI SYSTEMS
K Number: K913289
·
Decision Sep 5, 1991
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
101
Review Days
43
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Basic Information
- Device Name
- MASTERPIECES(TM)/MICRO/MINI SYSTEMS
- K Number
- K913289
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Storz Instrument Co.
- Date Received
- July 24, 1991
- Decision Date
- September 5, 1991
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | Oct 10, 1997 | Substantially Equivalent |
| K971439 | STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES | Jun 17, 1997 | Substantially Equivalent |
| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | Feb 3, 1997 | Substantially Equivalent |
| K960024 | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH | Sep 20, 1996 | Substantially Equivalent |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | Sep 18, 1996 | Substantially Equivalent |
| K960003 | STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION | Aug 29, 1996 | Substantially Equivalent |
| K962131 | STORZ D4600 AIR EXCHANGE LINE PACK | Aug 23, 1996 | Substantially Equivalent |
| K961831 | STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK | Aug 6, 1996 | Substantially Equivalent |