FDA Registration
Active
🇩🇪 Germany
9MM BICEPTOR TAP
Reg #: 8010764
·
FEI: 3002465897
·
Expires 2025
Products
1
Proprietary Names
78
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMITH & NEPHEW ORTHOPAEDICS, GMBH
- Registration Number
- 8010764
- FEI Number
- 3002465897
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ALEMANNENSTRASSE 14
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
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
US Agent
- Business Name
- SMITH & NEPHEW, INC.
- Contact Name
- Lisa Ewing
- Address
- 2875 Railroad St
- City
- Pittsburgh
- State
- PA
- ZIP
- 15222
- Country
- US
- [email protected]
- Phone
- 412 4199765
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2012-12-07 |
Proprietary Names
9MM BICEPTOR TAP
DYONICS POWERMAX ELITE HANDPIECE HAND-CONTROLLED WITH OPPOSITE-SIDE SUCTION LEVER
8.5 MM CANNULATED DRILL
PIN DRIVER FOR 7505 DRILL/REAMER
8 MM ENDOSCOPIC DRILL XL
DRILL TIP PASSING PIN 2.7 MM X 15 INCH, STERILE 6 PER BOX
6.5 MM CANNULATED DRILL
ENDOSCOPIC CANNULATED DRILL BIT, 4.5 MM, STERILE
5.5 MM CANNULATED DRILL
DYONICS 1/4 JCBS STL DRL SML BAT HND PC
10.5 MM ENDOSCOPIC CANNULATED DRILL BIT
3.2MM DRILL & GUIDE RAPTORMITE 3.7
PASSING PIN DRILL TIP 2.7 MM X 15 INCH GRADUATIONS TO 180 MM
10.5 MM CANNULATED DRILL
8.5 MM ENDOSCOPIC DRILL
TRE-CORE,TREPHINE 12MM
7.5 MM CANNULATED DRILL
ZIMMER DRILL (HUDSON MODIFIED TRINKLE)
HALLU LOCK
Endobutton drill tip, passing pin 2.7mm x 15
HALLU-FIX
Raptormite 3.7
Large QWIX
Dynomite 1.6mm drill & guide
Spyromite & MINITAC
Endobutton drill tip, passing pin 2.4mm x 15
Drill tip, passing pin w/graduation to 180mm
QWIX
Endoscopic Cannula Drill Bit 4.5mm
Raptormite 3
PANTA
13 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
7.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
5.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
7 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
DRILL ENDOBUTTON 4.5MM NON-CANN
HUDSON REAMER
WIRE/PIN DRIVER FOR 7505 DRILL/REAMER
8.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
2.7 MM X 15 INCH 38 CM DRILL-TIP PASSING PIN, NON-STERILE 6 PER PACKAGE
SVCE,MOT DR UNIT, HNDCONT POWERMAX ELITE
1.8MM DRILL & GUIDE SPYROMITE/MINI 2
9 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
SYNTHES REAMER
9.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
MTO 12.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
6 MM ENDOSCOPIC DRILL
MALLET WITH NYLON ENDS
RFB SMALL BONE WIRE DRIVER
12 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
9.5 MM CANNULATED DRILL
6.5 MM ENDOSCOPIC DRILL
13.5 MM CANNULATED DRILL
11.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
DYONICS WIRE DRVR SM BAT HANDPIECE
12.5 MM ENDOSCOPIC CANNULATED DRILL BIT
DYONICS 5/32 JACOBS STYLE DRL SML BATT
DRILL RAPTORMITE 3 SUTURE ANCHOR
11.5 MM ENDOSCOPIC CANNULATED DRILL BIT
2.6MM DRILL & GUIDE RAPTORMITE 3
1.6MM DRILL & GUIDE DYNOMITE 2
11.5 MM CANNULATED DRILL
DYONICS ZIMMER HT RMR SML BAT HNDPC
5 MM CANNULATED DRILL
5.5 MM ENDOSCOPIC CANNULATED DRILL BIT
6.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
9.5 MM ENDOSCOPIC CANNULATED DRILL BIT
6 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
9 MM ENDOSCOPIC DRILL XL
DYONICS POWERMAX ELITE HANDPIECE HAND-CONTROLLED WITH OPPOSITE-SIDE SUCTION LEVER REFURBISHED
10 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
11 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
7.5 MM ENDOSCOPIC DRILL
12.5 MM CANNULATED DRILL
DYONICS SYNTHS QUCK CON DRL SM BAT HNDPC
Straight Cut Reciprocating Rasp 3mm Connection
10.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
8 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED
Establishment Types
Manufacture Medical Device