FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K Number: K982155
·
Decision Aug 31, 1998
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
16
Review Days
74
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Basic Information
- Device Name
- SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM
- K Number
- K982155
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Influence, Inc.
- Date Received
- June 18, 1998
- Decision Date
- August 31, 1998
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Influence, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981677 | REPOSE BONE SCREW SYSTEM | Aug 27, 1999 | Substantially Equivalent |
| K991792 | CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE | Aug 12, 1999 | Substantially Equivalent |
| K992277 | STAPLETAC BONE ANCHOR SYSTEM | Jul 30, 1999 | Substantially Equivalent |
| K991122 | CRYO-MONO CRYOGRNIC SYSTEM | Jul 1, 1999 | Substantially Equivalent |
| K990160 | MICROTAC-BONE ANCHOR SYSTEM | Feb 16, 1999 | Substantially Equivalent |
| K990095 | STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM | Feb 1, 1999 | Substantially Equivalent |
| K983325 | IN-PROBE II URODYNAMIC SYSTEM | Nov 24, 1998 | Substantially Equivalent |
| K981631 | INFLUENCE CLIP SYSTEM | Jul 28, 1998 | Substantially Equivalent |
| K980482 | TRIANGLE SLING | Mar 27, 1998 | Substantially Equivalent |
| K972622 | STRAIGHT-IN BONE SCREW FIXATION SYSTEM | Oct 9, 1997 | Substantially Equivalent |