FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
SPOON PLATE
K Number: K931690
·
Decision Jun 7, 1994
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
47
Review Days
428
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Basic Information
- Device Name
- SPOON PLATE
- K Number
- K931690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Onyx Medical Corp.
- Date Received
- April 5, 1993
- Decision Date
- June 7, 1994
- 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 Onyx Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K942022 | FACE-IT SHIELD | Jul 8, 1994 | Substantially Equivalent |
| K934614 | MINI FRAGMENT PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931692 | T-PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931684 | EPIPHYSIS PLATE | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931680 | CANNULATED CANCELLOUS SCREW | May 4, 1994 | Substantially Equivalent for Some Indications |
| K931679 | BUTTRESS PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K934615 | CANCELLOUS BONE SCREW | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931683 | CLOVERLEAF PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931693 | 1/3 TUBULAR PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |
| K931687 | MULTIPLE FRAGMENT PLATE | Apr 25, 1994 | Substantially Equivalent for Some Indications |