FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOMET BONE PLATES
K Number: K875086
·
Decision Jan 14, 1988
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
60
Review Days
36
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Basic Information
- Device Name
- ORTHOMET BONE PLATES
- K Number
- K875086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Orthomet, Inc.
- Date Received
- December 9, 1987
- Decision Date
- January 14, 1988
- 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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|---|---|---|---|
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| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | Dec 28, 1994 | Substantially Equivalent |
| K930771 | PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM | Nov 30, 1994 | Substantially Equivalent for Some Indications |
| K926334 | AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER | Oct 18, 1994 | Substantially Equivalent for Some Indications |
| K932677 | AXIOM TOTAL KNEE SYSTEM | Oct 14, 1994 | Substantially Equivalent |
| K931678 | ORTHOMET LHMC FEMORAL STEM | Oct 14, 1994 | Substantially Equivalent |
| K931333 | ORTHOMET ACETABULAR CUP SYSTEM | Oct 14, 1994 | Substantially Equivalent |
| K923243 | PERFECTA TOTAL HIP SYSTEM | Jan 7, 1994 | Substantially Equivalent |