FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
THORACIC ANTERIOR SPINAL FIXATION PLATE
K Number: K910874
·
Decision Feb 3, 1992
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
655
Applicant Total
9
Review Days
339
Basic Information
- Device Name
- THORACIC ANTERIOR SPINAL FIXATION PLATE
- K Number
- K910874
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- TERRAY MANUFACTURING, INC.
- Date Received
- March 1, 1991
- Decision Date
- February 3, 1992
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
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Other Clearances by TERRAY MANUFACTURING, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K882934 | CASF CANCELLOUS BONE SCREW, BT650 | Oct 13, 1988 | Substantially Equivalent |
| K882871 | CASF DRILL GUIDE DG 170 | Sep 23, 1988 | Substantially Equivalent for Some Indications |
| K883125 | CASF STERILIZATION TRAY | Aug 10, 1988 | Substantially Equivalent |
| K883193 | CASF STERILIZATION TRAY | Aug 10, 1988 | Substantially Equivalent |
| K870085 | ANTERIOR SPINAL FIXATION PLATE | Jun 30, 1987 | Substantially Equivalent |
| K870082 | BONE PLATE | May 6, 1987 | Substantially Equivalent |
| K870083 | FERRAY EXTRACTOR | Feb 26, 1987 | Substantially Equivalent |
| K870084 | RD 140 SURGICAL BENDER | Jan 28, 1987 | Substantially Equivalent |