FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
BROAD SELF-COMPRESSING PLATE
K Number: K905355
·
Decision Jan 4, 1991
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
23
Review Days
37
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Basic Information
- Device Name
- BROAD SELF-COMPRESSING PLATE
- K Number
- K905355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- O'Tec Corp.
- Date Received
- November 28, 1990
- Decision Date
- January 4, 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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Other Clearances by O'Tec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K943293 | SCC22/ SCC26 SHOWER COMMODE CHAIR | Aug 19, 1994 | Substantially Equivalent |
| K910093 | FUTURA FEMORAL HIP STEM | Jul 1, 1991 | Substantially Equivalent |
| K905333 | U.S. TYPE CRUCIATE SLOT BONE SCREW | Jan 4, 1991 | Substantially Equivalent for Some Indications |
| K905347 | HAGIE PIN | Jan 4, 1991 | Substantially Equivalent for Some Indications |
| K905357 | CORTICAL BONE SCREW (EUROPEAN STYLE) | Jan 4, 1991 | Substantially Equivalent for Some Indications |
| K905358 | CANCELLOUS SCREW | Jan 4, 1991 | Substantially Equivalent for Some Indications |
| K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL | Dec 11, 1990 | Substantially Equivalent |
| K905344 | KNOWLES PIN | Dec 11, 1990 | Substantially Equivalent |
| K905362 | BARBED SQUARE STAPLE | Dec 11, 1990 | Substantially Equivalent |
| K905338 | SIDE PLATE | Dec 11, 1990 | Substantially Equivalent |