FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SLEEP-IN BONE SCREW SYSTEM
K Number: K972023
·
Decision Aug 25, 1997
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
212
Applicant Total
16
Review Days
84
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Basic Information
- Device Name
- SLEEP-IN BONE SCREW SYSTEM
- K Number
- K972023
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Influence, Inc.
- Date Received
- June 2, 1997
- Decision Date
- August 25, 1997
- Product Code
- LRK
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| LRK | Device, Anti-Snoring | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRK), ordered by most recent decision date.
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ShaeferH
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Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
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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 |
| K982155 | SHORT STRAIGHT-IN BONE SCREW FIXATION SYSTEM | Aug 31, 1998 | Substantially Equivalent |
| K981631 | INFLUENCE CLIP SYSTEM | Jul 28, 1998 | Substantially Equivalent |
| K980482 | TRIANGLE SLING | Mar 27, 1998 | Substantially Equivalent |