Definition: Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.
| Device Type ID | 4674 |
| Device Name | Bone Fixation Cerclage, Sublaminar |
| Physical State | Metallic Wire, Polyester Bands |
| Technical Method | Wrapped Around A Portion Of The Sublaminar, Posterior Spine For Temporary Stabilization During Spinal Fusion Procedures. May Be Used In Conjunction With Other Medical Implants Made Of Similar Metals Whenever Wiring" May Help Secure The Attachment Of |
| Target Area | Sublaminar, Posterior Spine |
| Regulation Description | Bone Fixation Cerclage. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3010 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OWI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4674 |
| Device | Bone Fixation Cerclage, Sublaminar |
| Product Code | OWI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Fixation Cerclage. |
| CFR Regulation Number | 888.3010 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COUSIN BIOTECH S.A.S. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GLOBE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMPLANET S.A. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
K2M, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDICREA INTERNATIONAL S.A. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZIMMER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 6 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Fracture | 2 |
Naturally Worn | 2 |
Loosening Of Implant Not Related To Bone-Ingrowth | 2 |
Device Operates Differently Than Expected | 1 |
Fastener | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 20 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | OrthoPediatrics Corp | II | Jun-09-2017 |