FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
K Number: K862230
·
Decision Aug 29, 1986
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
111
Review Days
79
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Basic Information
- Device Name
- WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
- K Number
- K862230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Buckman Co., Inc.
- Date Received
- June 11, 1986
- Decision Date
- August 29, 1986
- 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 Buckman Co., Inc.
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|---|---|---|---|
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| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Jan 25, 1996 | Substantially Equivalent |
| K945756 | IMAGN(TM) 2000 SYSTEM | Dec 19, 1995 | Substantially Equivalent |
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| K951117 | LIHTAN 532 LASER | Oct 18, 1995 | Substantially Equivalent |
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