FDA UDI
In Commercial Distribution
🇺🇸 United States
Apollo Labral Anchor, Peek 3.5mm x 13mm
DI: M209S32130
·
Model: S-3213
·
BIOPRO, INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Apollo Labral Anchor, Peek 3.5mm x 13mm
- Primary DI
- M209S32130
- Version / Model
- S-3213
- Company Name
- BIOPRO, INC.
- Labeler DUNS
- 618749857
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-12-31
- Public Version
- 5
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 9028c0e3-e87c-48a3-8a01-3d69906d2a21
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NOV | Anchor, Suture, Bone Fixation, Metallic | Orthopedic | 888.3030 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36174 | Ligament bone anchor | A non-bioabsorbable device designed to be implanted into bone specifically to attach the ends of a ligament (synthetic or natural source) to the bone, e.g., during reconstructive knee surgery. The device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)]. | No | Obsolete |
| 45612 | Soft-tissue/mesh anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M209S32130 | HIBCC |