FDA Registration
Active
🇺🇸 United States
ProCinch No Button Adjustable Loop Implant
Reg #: 2936485
·
FEI: 2936485
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRYKER ENDOSCOPY
- Registration Number
- 2936485
- FEI Number
- 2936485
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5900 Optical Ct
- City
- SAN JOSE
- State
- CA
- ZIP
- 95138
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210078
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2021-06-07 |
Proprietary Names
ProCinch No Button Adjustable Loop Implant
6.5mm AlphaVent Suture Anchor PEEK 3 strands of 1.4mm XBraid TT Suture Tape
6.5mm AlphaVent Suture Anchor PEEK 3 strands of 2 XBraid S Suture
5.5mm AlphaVent Suture Anchor PEEK 3 Strands of 2 XBraid S Suture with Needle
4.75mm AlphaVent Suture Anchor PEEK 3 strands of 1.4mm XBraid TT Suture Tape
4.75mm AlphaVent Suture Anchor PEEK 3 strands of 2 XBraid S Suture with Needles
5.5mm AlphaVent Suture Anchor PEEK 2 strands of 2mm XBraid TT Suture Tape
4.75 mm AlphaVent Suture Anchor PEEK 2 strands of 2 XBraid S Suture
4.75mm AlphaVent Suture Anchor PEEK 2 strands of 2mm XBraid TT Suture Tape with Needles
4.75mm AlphaVent Suture Anchor PEEK 3 strands of 2 XBraid S Suture
5.5mm AlphaVent Suture Anchor PEEK 3 strands of 1.4mm XBraid TT Suture Tape
5.5mm AlphaVent Suture Anchor PEEK 2 Strands of 2 XBraid S Suture
5.5mm AlphaVent Suture Anchor PEEK 1 strands of 2mm XBraid TT Suture Tape and 1 strand of 1.4mm XBraid TT Suture Tape
4.75mm AlphaVent Suture Anchor PEEK 3 strands of 1.4mm XBraid TT Suture Tape with Needles
4.75mm AlphaVent Suture Anchor PEEK 2 strands of 1.4mm XBraid TT Suture Tape
5.5mm AlphaVent Suture Anchor PEEK 2 strands of 1.4mm XBraid TT Suture Tape
4.75mm AlphaVent Suture Anchor PEEK 1 strand of 2mm XBraid TT Suture Tape and 1 Strand of 2 XBraid S Suture
4.75mm AlphaVent Suture Anchor PEEK 1 strand of 2mm XBraid TT Suture Tape and 1 Strand of 1.4mm XBraid TT Suture Tape
4.75mm AlphaVent Suture Anchor PEEK 2 strands of 2mm XBraid TT Suture Tape
5.5mm AlphaVent Suture Anchor PEEK 3 Strands of 2 XBraid S Suture
6.5mm AlphaVent Suture Anchor PEEK 1 strand of 2mm XBraid TT Suture Tape and 1 strand of 1.4mm XBraid TT Suture Tape
5.5mm AlphaVent Suture Anchor PEEK 1 strands of 2mm XBraid TT Suture Tape and 1 strand of 2 XBraid S Suture
6.5mm AlphaVent Suture Anchor PEEK 1 strand of 2mm XBraid TT Suture Tape and 1 strand of 2 XBraid S Suture
Establishment Types
Manufacture Medical Device