FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM
K Number: K853033
·
Decision Sep 24, 1985
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
2
Review Days
68
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Basic Information
- Device Name
- HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM
- K Number
- K853033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- A.W. Showell (Surgicraft) , Ltd.
- Date Received
- July 18, 1985
- Decision Date
- September 24, 1985
- 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 A.W. Showell (Surgicraft) , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K844608 | SURGICRAFT COPELAND DISPOSABLE | May 1, 1985 | Substantially Equivalent |