FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHOPEDIC CUSTOM SURGICAL KIT
K Number: K844595
·
Decision Aug 21, 1985
Classifications
1
FEI Numbers
1106
Registration Numbers
1106
Same Product Code
57
Applicant Total
9
Review Days
268
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Basic Information
- Device Name
- ORTHOPEDIC CUSTOM SURGICAL KIT
- K Number
- K844595
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Xanmed Corp.
- Date Received
- November 26, 1984
- Decision Date
- August 21, 1985
- 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 Xanmed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K864623 | OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT | Jan 14, 1987 | Substantially Equivalent |
| K844596 | EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT | Aug 1, 1985 | Unknown |
| K844593 | CARDIOVASCULAR CUSTOM SURGICAL KIT | Jun 21, 1985 | Substantially Equivalent |
| K844594 | NEURO CUSTOM SURGICAL KIT | Jun 13, 1985 | Substantially Equivalent |
| K851906 | SURGICAL EYE PACK | May 21, 1985 | Substantially Equivalent |
| K844597 | MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT | Apr 8, 1985 | Substantially Equivalent |
| K843642 | SUBCLAVIAN LEAD INTRODUCER SYS | Oct 23, 1984 | Substantially Equivalent |
| K843641 | CATHETER INTRODUCER SYSTEM | Oct 23, 1984 | Substantially Equivalent |