FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW
K Number: K922322
·
Decision Aug 5, 1992
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
20
Review Days
79
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Basic Information
- Device Name
- ALPHATEC 3.5MM ZNNULATED CORTICAL LAG SCREW
- K Number
- K922322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alphatec Mfg., Inc.
- Date Received
- May 18, 1992
- Decision Date
- August 5, 1992
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Alphatec Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033090 | ICON POLYAXIAL PEDICLE SCREW SYSTEM | Mar 26, 2004 | Substantially Equivalent |
| K023299 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM | Dec 11, 2002 | Substantially Equivalent |
| K020356 | ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM | Jul 23, 2002 | Substantially Equivalent |
| K993513 | DELTALOC ANTERIOR CERVICAL PLATE SYSTEM | Apr 26, 2000 | Substantially Equivalent |
| K993873 | ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD | Jan 3, 2000 | Substantially Equivalent |
| K992350 | PYLON INTRAMEDULLAARY NAIL SYSTEM | Sep 22, 1999 | Substantially Equivalent |
| K980788 | ALPHATEC WIRE EXTERNAL FIXATION SYSTEM | May 22, 1998 | Substantially Equivalent |
| K964400 | ALPHATEC EXTERNAL FIXATION SYSTEM | Apr 28, 1997 | Substantially Equivalent |
| K951846 | MIRAGE SPINAL SYSTEM FOR SEVERE SPONDYLOLISTHESIS | Feb 14, 1996 | Substantially Equivalent for Some Indications |
| K926417 | ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW | Sep 28, 1994 | Substantially Equivalent |