FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RETROGRADE KNIFE, DISPOSABLE #TM-1613
K Number: K873711
·
Decision Nov 2, 1987
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
8
Applicant Total
29
Review Days
48
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Basic Information
- Device Name
- RETROGRADE KNIFE, DISPOSABLE #TM-1613
- K Number
- K873711
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Arthropedics, Inc.
- Date Received
- September 15, 1987
- Decision Date
- November 2, 1987
- Product Code
- HTS
- 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 |
|---|---|---|---|
| HTS | Knife, Orthopedic | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTS), ordered by most recent decision date.
CUSTOM ORTHOPAEDIC TRAYS (PACKS)
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ACUFLEX DISPOSABLE KNIVES
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SPINAL MICROKNIFE
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TRIANGULAR KNIFE, DISPOSABLE #TM-1611
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BANANA KNIFE, DISPOSABLE #TM-1612
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FDA Class 1
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STANDARD KNIFE, DISPOSABLE #TM-1610
FDA 510(k)
FDA Class 1
·Orthopedic
Other Clearances by Arthropedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873619 | ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS) | Jan 14, 1988 | Substantially Equivalent |
| K873655 | MONOPOLAR CAUTERY RETROGADE TIP #TM-1703 | Dec 15, 1987 | Substantially Equivalent |
| K873653 | MONOPOLAR CAUTERY BLADE TIP #TM-1701 | Dec 15, 1987 | Substantially Equivalent |
| K873654 | MONOPOLAR CAUTERY CONICAL TIP #TM-1702 | Dec 15, 1987 | Substantially Equivalent |
| K873387 | VIDEO ARTHROSCOPE, 1.7MM X 55 MM | Nov 25, 1987 | Substantially Equivalent |
| K873504 | CUP BIOPSY FORCEPS, RIGHT | Nov 2, 1987 | Substantially Equivalent |
| K872533 | THE CART | Nov 2, 1987 | Substantially Equivalent |
| K873501 | SCISSOR, LEFT | Nov 2, 1987 | Substantially Equivalent |
| K873502 | SCISSOR, RIGHT | Nov 2, 1987 | Substantially Equivalent |
| K873512 | SERRATED GRASPING FORCEPS, RIGHT | Nov 2, 1987 | Substantially Equivalent |