FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
OMNIFIT BONE SCREW
K Number: K873251
·
Decision Sep 18, 1987
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
178
Review Days
32
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Basic Information
- Device Name
- OMNIFIT BONE SCREW
- K Number
- K873251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Osteonics Corp.
- Date Received
- August 17, 1987
- Decision Date
- September 18, 1987
- 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 Osteonics Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K980070 | OSTEONICS HA-COATED DEVICES | Jul 23, 1999 | Substantially Equivalent |
| K984375 | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY | Apr 30, 1999 | Substantially Equivalent |
| K982798 | OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM | Mar 25, 1999 | Substantially Equivalent |
| K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | Feb 24, 1999 | Substantially Equivalent |
| K990203 | OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | Feb 18, 1999 | Substantially Equivalent |
| K990158 | OSTEONICS COMBINATION SCREW RING/BLOCKER | Feb 1, 1999 | Substantially Equivalent |
| K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS | Dec 18, 1998 | Substantially Equivalent |
| K984353 | OSTEO 9MM IC TIBIAL NAIL | Dec 16, 1998 | Substantially Equivalent |
| K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM | Dec 16, 1998 | Substantially Equivalent |