FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS
K Number: K932853
·
Decision Feb 22, 1994
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
15
Review Days
257
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Basic Information
- Device Name
- PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS
- K Number
- K932853
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Osteo Systems, Inc.
- Date Received
- June 10, 1993
- Decision Date
- February 22, 1994
- Product Code
- JEL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| JEL | Curette, Biopsy, Bronchoscope (Rigid) | FDA class 2 | Ear, Nose, Throat |
Other Clearances by Applied Osteo Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K935383 | FEMROD AND FEMROD RECON INSERT | Mar 21, 1995 | Substantially Equivalent |
| K933995 | TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION | Jan 27, 1995 | Substantially Equivalent |
| K944501 | TRUE/FLEX INTRAMEDULLARY ROD END-CAP | Nov 28, 1994 | Substantially Equivalent |
| K941048 | TRUE/LOK MONOLATERAL/BILATERAL FIXATOR | Oct 3, 1994 | Substantially Equivalent |
| K943160 | INTERFERENCE SCREW | Sep 30, 1994 | Substantially Equivalent for Some Indications |
| K934148 | TRUE/FLEX CLAVICLE RODS | Feb 22, 1994 | Substantially Equivalent |
| K931578 | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR | Feb 22, 1994 | Substantially Equivalent |
| K926465 | FEMORAL INTRAMEDULLARY RODS | Aug 25, 1993 | Substantially Equivalent |
| K924656 | TRUE/ FLEX FIBULA RODS | Nov 24, 1992 | Substantially Equivalent |
| K924657 | TRUE/FLEX METATARSAL RODS | Nov 24, 1992 | Substantially Equivalent |