FDA Registration
Active
🇺🇸 United States
HEALICOIL REGENESORB 5.5mm Suture Anchor with Three ULTRABRAID (#2) Sutures (Blue/Cobraid Blue/Cobraid Black)
Reg #: 1219602
·
FEI: 1219602
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMITH & NEPHEW INC.
- Registration Number
- 1219602
- FEI Number
- 1219602
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ENDOSCOPY, 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD.
- City
- MANSFIELD
- State
- MA
- ZIP
- 02048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123393
Owner / Operator
- Firm Name
- Smith & Nephew, Inc.
- Operator Number
- 1020279
- Address
- 2875 Railroad Street
- City
- Pittsburgh
- State
- PA
- Postal Code
- 15222
- Country
- US
- Correspondent
- Lisa Ewing
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2014-01-14 |
Proprietary Names
HEALICOIL REGENESORB 5.5mm Suture Anchor with Three ULTRABRAID (#2) Sutures (Blue/Cobraid Blue/Cobraid Black)
HEALICOIL REGENESORB 5.5mm Suture Anchor with Two ULTRABRAID (#2) Sutures (Blue/Cobraid Blue)
HEALICOIL REGENESORB 4.75mm Suture Anchor with Two ULTRABRAID (#2) Sutures (Blue/Cobraid Blue)
Dilator, HEALICOIL REGENESORB 5.5mm, Disposable, 72203952
HEALICOIL REGENESORB 5.5 MM THREADED DILATOR, DISPOSABLE
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL
HEALICOIL REGENESORB 4.75 MM THREADED DILATOR, REUSABLE
HEALICOIL REGENESORB 5.5 MM THREADED DILATOR, REUSABLE
HEALICOIL REGENESORB 4.75 MM THREADED DILATOR, DISPOSABLE
HEALICOIL REGENESORB 5.5 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE BLUE AND ONE No.2 ULTRABRAID SUTURE
HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK
HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE COBRAID BLUE AND ONE ULTRABRAID SUTURE No.2
Establishment Types
Manufacture Medical Device