FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHOPAEDIC AND SPINAL RING CURRETTES
K Number: K882072
·
Decision Jun 17, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
17
Review Days
31
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ORTHOPAEDIC AND SPINAL RING CURRETTES
- K Number
- K882072
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5030
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Karlin Technology, Inc.
- Date Received
- May 17, 1988
- Decision Date
- June 17, 1988
- Product Code
- JXH
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| JXH | Methyl Methacrylate For Aneurysmorrhaphy | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JXH), ordered by most recent decision date.
ANEUROPLASTIC, MODEL 43-1290
FDA 510(k)
FDA Class 2
·Neurology
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
FDA 510(k)
FDA Class 2
·Neurology
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 |
| K882069 | SPINAL DISTRACTORS, SPANNERS | Jun 17, 1988 | Substantially Equivalent |
| K882077 | MICRODISCECTOMY CURRETTES | Jun 17, 1988 | Substantially Equivalent |