FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPINAL DISTRACTORS, SPANNERS
K Number: K882069
·
Decision Jun 17, 1988
Classifications
1
FEI Numbers
1106
Registration Numbers
1106
Same Product Code
57
Applicant Total
17
Review Days
31
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Basic Information
- Device Name
- SPINAL DISTRACTORS, SPANNERS
- K Number
- K882069
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Karlin Technology, Inc.
- Date Received
- May 17, 1988
- Decision Date
- June 17, 1988
- Product Code
- LXH
- 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 |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | FDA class 1 | Orthopedic |
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Other Clearances by Karlin Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K903969 | SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET | Sep 5, 1990 | Substantially Equivalent |
| K893201 | BONE PLATE | Apr 4, 1990 | Substantially Equivalent |
| K893203 | BONE SCREW | Apr 4, 1990 | Substantially Equivalent |
| K882525 | SPINAL MICROKNIFE | Sep 22, 1988 | Substantially Equivalent |
| K882519 | X-RAY MARKER | Aug 9, 1988 | Substantially Equivalent |
| K882520 | SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS | Jul 18, 1988 | Substantially Equivalent |
| K882073 | SPINAL NEEDLE | Jul 18, 1988 | Substantially Equivalent |
| K882524 | UNIVERSALLY ADJUSTABLE ARMBOARD | Jul 8, 1988 | Substantially Equivalent |
| K882072 | ORTHOPAEDIC AND SPINAL RING CURRETTES | Jun 17, 1988 | Substantially Equivalent |
| K882077 | MICRODISCECTOMY CURRETTES | Jun 17, 1988 | Substantially Equivalent |