FDA Registration
Active
🇩🇪 Germany
PROFYLE/BONE SCREW 1.2X12mm S/T
Reg #: 8010177
·
FEI: 3002821504
·
Expires 2025
Products
1
Proprietary Names
316
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRYKER LEIBINGER GMBH & CO. KG
- Registration Number
- 8010177
- FEI Number
- 3002821504
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BOTZINGER STRASSE 39-41
- City
- FREIBURG Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K062498
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 |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2008-01-31 |
Proprietary Names
PROFYLE/BONE SCREW 1.2X12mm S/T
OBLIQUE L PLATE 6H RIGHT
2.3X20mm BONE SCREWSCROSSPINSELFTAPPING
2.3 M PROFYLE HAND LOCK T-PLATE,NAR,6H
PROFYLE/S PLATE MED STR 4HOLE
PROFYLE/BONE SCREW 1.7X5mm S/T
PROFYLE/XS 3-D PLATE 2X2 HOLE
PROFYLE/M COMP PLATE 90? REG 10H
L PROFYLE HAND COMP PLATE,STRAI,BAR,5H
1.7X11MM LOCKING SCREWS,CROSS-PIN,SELF-T
1.7X7MM LOCKING SCREWS,CROSS-PIN,SELF-T
1.7X12MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/BONE SCREW 2.3X24mm S/T
1.7 S VARIAX HAND LOCK ROTATION PLATE,5H
1.9X5mm EMERG SCREWSCROSSPINSELFT
2.3X24MM LOCKING SCREWS,CROSS-PIN,SELF-T
1.7 S PROFYLE HAND LOCK 3-D PLATE,4X2H
PROFYLE/S PLATE T 90? REG 7H
2.3 M PROFYLE HAND LOCK PLATE STRAIGHT BAR 4H
PROFYLE/BONE SCREW 2.3X23mm S/T
PROFYLE/BONE SCREW 1.7X7mm S/T
PROFYLE/XS 90DEG PLATE 8 HOLE NA
PROFYLE/S CONDYLAR PLATE BAR 5H RT
OBLIQUE L PLATE 6H LEFT
PROFYLE/S T PLATE 90? 10H REG
1.7X6mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/L COMP PLATE T LT OBQE6H
1.4X5mm EMERG SCREWSCROSSPINSELFT
PROFYLE/BONE SCREW 2.3X21mm S/T
L PROFYLE HAND COMP PLATE,STRAI,BAR,8H
PROFYLE/BONE SCREW 2.3X28mm S/T
2.3 M PROFYLE HAND LOCK 3-D PLATE,3X2H
1.2X16mm BONE SCREWSCROSSPINSELFT
PROFYLE/BONE SCREW 1.7X23mm S/T
PROFYLE/BONE SCREW 1.2X4mm S/T
PROFYLE/M PLATE L 90? REG RT 6H
1.7 S PROFYLE HAND LOCK ROTATION PLATE,5H
1.7X9mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/L COMP PLATE 4H W/BAR
PROFYLE/BONE SCREW 2.3X16mm S/T
1.7 S PROFYLE HAND LOCK 3-D REPL PL,4X2H
PROFYLE/1.7S-S PLATE 16H STR
2.3 M VARIAX HAND LOCK ROTATION PLATE,5H
M PROFYLE HAND COMP T-PLATE,NAR,6H
PROFYLE/BONE SCREW 1.7X17mm S/T
PROFYLE/BONE SCREW 2.3X18mm S/T
1.4X3mm EMERG SCREWSCROSSPINSELFT
PROFYLE/BONE SCREW 2.3X17mm S/T
M PROFYLE HAND COMP T-PLATE,REG,7H
PROFYLE/BONE SCREW 2.3X15mm S/T
PROFYLE/S PLATE T 90? NRW 6H
PROFYLE/3D PLATE
2.3X12mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/M 3-D PLATE 3X2 HOLE
PROFYLE/EMERG BONE SCREW 2.5X8mm
L PROFYLE HAND COMP T-PLATE,OBLI,LE,6H
PROFYLE/M COMP PLATE TBVL NRW R6H
PROFYLE/L COMP PLATE STR 8H
PROFYLE/BONE SCREW 1.2X18mm S/T
1.7X5mm BONE SCREWSCROSSPINSELFTAPPING
L PROFYLE HAND COMP PLATE,STRAI,BAR,4H
PROFYLE/BONE SCREW 2.3X26mm S/T
PROFYLE/EMERG BONE SCREW 1.9X10 S/T
1.7X15mm BONE SCREWSCROSSPINSELFTAPPING
1.7 S PROFYLE HAND LOCK Z-PLATE,NAR,9H
2.3X6mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/M CONDYLAR PLATE RT 6H
2.3X15mm BONE SCREWSCROSSPINSELFTAPPING
1.7X24mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/BONE SCREW 1.7X18mm S/T
L PROFYLE HAND COMP L-PLATE,LE,6H
PROFYLE/M COMP PLATE L-SHAPE
PROFYLE/BONE SCREW 1.7X10mm S/T
WASHER FOR 1.7 mm BONE SCREWS
1.7X7mm BONE SCREWSCROSSPINSELFTAPPING
2.3 M PROFYLE HAND LOCK 3-D PLATE,4X2H
1.2X5mm BONE SCREWSCROSSPINSELFT
PROFYLE/M COMP PLATE STR 5H
1.7X15MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/BONE SCREW 2.3X34mm S/T
L PROFYLE HAND COMP T-PLATE,6H
1.7X11mm BONE SCREWSCROSSPINSELFTAPPING
2.3 M PROFYLE HAND LOCK PLATE,STRAI,4H
PROFYLE/BONE SCREW 1.2X13mm S/T
PROFYLE/BONE SCREW 1.2X14mm S/T
PROFYLE/S CONDYLAR PLATE 1 HOLE
PROFYLE/M PLATE STR MED 4H
1.2X6mm BONE SCREWSCROSSPINSELFT
2.3 M PROFYLE HAND LOCK 3-D PLATE,2X2+2H
2.3 M PROFYLE HAND LOCK L-PLATE,LE,6H
2.3X8mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/XS 3-D PLATE 3X2 HOLE
PROFYLE/BONE SCREW 1.2X11mm S/T
PROFYLE/BONE SCREW 1.7X21mm S/T
PROFYLE/BONE SCREW 2.3X8mm S/T
1.7X14MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/EMERG BONE SCREW 2.5X10mm
1.2X20mm BONE SCREWSCROSSPINSELFT
1.7X8MM LOCKING SCREWS,CROSS-PIN,SELF-T
1.7X8mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/BONE SCREW 1.2X6M S/T
PROFYLE/BONE SCREW 1.2X10mm S/T
1.7 S PROFYLE HAND LOCK L-PLATE,LE,6H
1.7 S PROFYLE HAND LOCK T-PLATE,NAR,6H
PROFYLE/EMERG BONE SCREW 1.9X8 S/T
PROFYLE/BONE SCREW 2.3X19mm S/T
2.3X22MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/BONE SCREW 2.3X12mm S/T
M PROFYLE HAND COMP PLATE,STRAI,6H
2.3X9mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/M COMP PLATE TBVL NRW L6H
PROFYLE/S 3-D PLATE 2X2 HOLE
PROFYLE/M 3-D PLATE 2X2 HOLE
PROFYLE/M 3D PLATE 2X2+2H
2.3 M PROFYLE HAND LOCK LE MC V PLATE,5H
PROFYLE/BONE SCREW 2.3X11mm S/T
2.5X6mm EMERG SCREWSCROSSPINSELFT
2.3 M PROFYLE HAND ROTATION PLATE,5H
L PROFYLE HAND COMP L-PLATE,RI,6H
2.3 L PROFYLE HAND ROTATION PLATE,5H
1.2X7mm BONE SCREWSCROSSPINSELFT
2.3 M PROFYLE HAND LOCK Z-PLATE,NAR,13H
1.7 S PROFYLE HAND LOCK T-PLATE,WIDE,8H
1.2X9mm BONE SCREWSCROSSPINSELFT
PROFYLE/L COMP PLATE L 90? RT6H
1.7 S PROFYLE HAND LOCK PLATE,STRAI,4H
PROFYLE/M COMP PLATE L 90? L 6H
PROFYLE/M PLATE T BVL NRW LT 6H
PROFYLE/BONE SCREW 1.7X11mm S/T
2.3 M PROFYLE HAND LOCK ROTATION PLATE,5H
PROFYLE/S PLATE Y-NRW 7H
1.7 S PROFYLE HAND LOCK 3-D PLATE,3X2H
1.7X10mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/M REPLANT PLATE 4X2H
M PROFYLE HAND COMP L-PLATE,RI,6H
1.7 S PROFYLE HAND LOCK L-PLATE,RI,6H
PROFYLE/M 3-D PLATE 4X2 HOLE
PROFYLE/XS PLATE T 90DG NARROW
1.7X18mm BONE SCREWSCROSSPINSELFTAPPING
2.3X26mm BONE SCREWSCROSSPINSELFTAPPING
2.3X18mm BONE SCREWSCROSSPINSELFTAPPING
1.7X18MM LOCKING SCREWS,CROSS-PIN,SELF-T
1.7 S PROFYLE HAND LOCK T-PLATE,REG,7H
1.2X10mm BONE SCREWSCROSSPINSELFT
2.3 M PROFYLE HAND LOCK PLATE,STRAI,16H
PROFYLE/M COMP PLATE STR 8H
PROFYLE/BONE SCREW 2.3X9mm S/T
PROFYLE/EMERG BONE SCREW 1.4X5
PROFYLE/EMERG BONE SCREW 1.4X9
PROFYLE/M CONDYLAR PLATE LT 5H
PROFYLE/BONE SCREW 2.3X30mm S/T
1.2X14mm BONE SCREWSCROSSPINSELFT
PROFYLE/M COMP PLATE 90? REG 7H
1.7X20MM LOCKING SCREWS,CROSS-PIN,SELF-T
1.7X20mm BONE SCREWSCROSSPINSELFTAPPING
2.3X6MM LOCKING SCREWS,CROSS-PIN,SELF-T
1.7X16mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/XS PLATE T-BEVL NRW RT
PROFYLE/M COMP PLATE L BVL LT 6H
PROFYLE/S PLATE L 90? REG RT 6H
1.2X8mm BONE SCREWSCROSSPINSELFT
PROFYLE/BONE SCREW 1.7X6mm S/T
2.3 M PROFYLE HAND LOCK 3-D REPL PL,4X2H
PROFYLE/S PLATE L 90? REG LT 6H
L-COMPRESSION PLATE/2.3MM
PROFYLE/L COMP PLATE T RT OBQE6H
PROFYLE/M PLATE L BVL REG LT 6H
2.3X13mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/BONE SCREW 1.2X20mm S/T
M PROFYLE HAND COMP PLATE,STRAI,BAR,4H
1.4X7mm EMERG SCREWSCROSSPINSELFT
2.3X15MM LOCKING SCREWS,CROSS-PIN,SELF-T
WASHER FOR 2.3mm BONE SCREWS
1.7 S PROFYLE HAND LOCK T-PLATE,NAR,10H
PLATE/CONDYLAR 6H LFT W/LONG
M PROFYLE HAND COMP CONDY-PLATE,RI,6H
PROFYLE/M CONDYLAR PLATE LT 6H
1.7X22MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/EMERG BONE SCREW 1.9X5
2.3X16mm BONE SCREWSCROSSPINSELFTAPPING
2.3X26MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/BONE SCREW 1.7X22mm S/T
PROFYLE/BONE SCREW 1.2X8mm S/T
PROFYLE/M COMP PLATE STR 6H
2.5X8mm EMERG SCREWSCROSSPINSELFT
1.7 S PROFYLE HAND LOCK 3-D PLATE,2X2H
L PROFYLE HAND COMP T-PLATE,NAR,6H
PROFYLE/XS PLATE STGHT 16 HOLE
PROFYLE/BONE SCREW 1.7X14mm S/T
M ROTATIONAL PLATE
PROFYLE/S PLATE STR 16HOLE
2.3X16MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/M PLATE T 90DG REG 7H
1.7X16MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/EMERG BONE SCREW 1.4X3
PROFYLE/M PLATE Y NRW 7H
PROFYLE/EMERG BONE SCREW 2.5X6mm
2.3X20MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/S CONDYLAR PLATE 5H RT
PROFYLE/S CONDYLAR PLATE BAR 5H LFT
PROFYLE/BONE SCREW 2.3X36mm S/T
PROFYLE/S 3D PLATE 2X2+2H
1.7 S PROFYLE HAND LOCK PLATE,STRAI,16H
PROFYLE/EMERG BONE SCREW 1.4X7
WASHER FOR 1.2 mm BONE SCREWS
2.3X8MM LOCKING SCREWS,CROSS-PIN,SELF-T
2.3 M PROFYLE HAND LOCK RI MC V PLATE,5H
PROFYLE/BONE SCREW 1.7X13mm S/T
PROFYLE/S PLATE T BVL NRW RT 6H
PROFYLE/S CONDYLAR PLATE 5H LFT
1.2X18mm BONE SCREWSCROSSPINSELFT
2.3 M PROFYLE HAND LOCK L-PLATE,RI,6H
PROFYLE/S REPLANT PLT 4X2H
2.3 M PROFYLE HAND LOCK 3-D PLATE,2X2H
2.3 M PROFYLE HAND LOCK Y-PLATE,NAR,7H
PROFYLE/BONE SCREW 1.2X7mm S/T
PROFYLE/M PLATE L BVL REG RT 6H
M PROFYLE HAND COMP Y-PLATE,NAR,7H
PROFYLE/BONE SCREW 2.3X14mm S/T
PROFYLE/BONE SCREW 1.7X20mm S/T
2.3X13mm LOCKING SCREWSCROSSPINSELFT
PROFYLE/BONE SCREW 1.2X5mm S/T
2.3X11mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/BONE SCREW 2.3X22mm S/T
PROFYLE/M PLATE L 90? REG LT 6H
PROFYLE/XS 3-D PLATE 4X2 HOLE
PROFYLE/M CONDYLAR PLATE RT 5H
PROFYLE/BONE SCREW 2.3X20mm S/T
PROFYLE/XS REPLANT PLATE 4X2H
PROFYLE/M COMP PLATE STR MED 4H
2.3 M PROFYLE HAND LOCK T-PLATE,WIDE,8H
1.7X14mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/L COMP PLATE 5H W/BAR
PROFYLE/1.7S-S PLATE 12H RIGHT
2.3X14mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/M PLATE T BVL NRW RT 6H
PROFYLE/S PLATE STGHT 4 HOLE
PROFYLE/BONE SCREW 2.3X7mm S/T
S-FIXATION PLATE/1.7MM SCREWS
2.3 M PROFYLE HAND LOCK T-PLATE,REG,7H
PROFYLE/BONE SCREW 1.2X9mm S/T
PROFYLE/L COMP PLATE T 90? 6H
M PROFYLE HAND T-PLATE,WIDE,8H
PROFYLE/S Z PLATE 9 HOLE
2.3X14MM LOCKING SCREWS,CROSS-PIN,SELF-T
1.9X10mm EMERG SCREWSCROSSPINSELFT
PROFYLE/M COMP PLATE Y NRW 7H
PROFYLE/BONE SCREW 2.3X6mm S/T
2.3X11MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/S 3-D PLATE 4X2 HOLE
L ROTATIONAL PLATE
PROFYLE/EMERG BONE SCREW 2.5X12mm
PROFYLE/M COMP PLATE STR 4H
PROFYLE/1.7S-S PLATE 12H LEFT
2.3X9MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/BONE SCREW 1.7X8mm S/T
PROFYLE/BONE SCREW 2.3X32mm S/T
PROFYLE/XS 3D PLATE 2X2+2HOLE
PROFYLE/M COMP PLATE T 90? NRW6H
PROFYLE/XS PLATE T-BEVL NRW LT
PROFYLE/L COMP PLATE STR 7H
2.3X22mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/BONE SCREW 1.7X12mm S/T
1.7X6MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/BONE SCREW 2.3X10mm S/T
PROFYLE BONECREW 1.7X15MM
PROFYLE/XS PLATE STGHT 4 HOLE
PROFYLE/L COMP PLATE L 90? LT6H
PROFYLE/M COMP PLATE L BVL RT 6H
1.7 S PROFYLE HAND LOCK 3-D PLATE,2X2+2H
M PROFYLE HAND ROTATION PLATE,5H
PROFYLE/S 3-D PLATE 3X2 HOLE
2.3X24mm BONE SCREWSCROSSPINSELFTAPPING
PROFYLE/M PLATE STR 4H
L PROFYLE HAND COMP T-PLATE,NAR,10H
L PROFYLE HAND ROTATION PLATE,5H
PLATE/CONDYLAR 6H RT W/LONGPIN
PROFYLE/BONE SCREW 1.7X9mm S/T
2.3X12MM LOCKING SCREWS,CROSS-PIN,SELF-T
2.3X10MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/L COMP PLATE T 90? 10H
PROFYLE/L COMP PLATE 6H W/BAR
PROFYLE/M V Z-SHAPE 13H
1.9X8mm EMERG SCREWSCROSSPINSELFT
PROFYLE/BONE SCREW 1.7X16mm S/T
1.9X12mm EMERG SCREWSCROSSPINSELFT
PROFYLE/BONE SCREW 2.3X13mm S/T
1.2X12mm BONE SCREWSCROSSPINSELFT
1.7X24MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/S PLATE T BVL NRW LT 6H
PROFYLE/BONE SCREW 2.3X38mm S/T
2.3X18MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/M PLATE T 90? NRW 6H
PROFYLE/BONE SCREW 1.7X24mm S/T
2.5X12mm EMERG SCREWSCROSSPINSELFT
1.7X13mm BONE SCREWSCROSSPINSELFTAPPING
M PROFYLE HAND COMP L-PLATE,LE,6H
1.7X22mm BONE SCREWSCROSSPINSELFTAPPING
1.7X10MM LOCKING SCREWS,CROSS-PIN,SELF-T
L PROFYLE HAND COMP PLATE,STRAI,BAR,6H
2.5X10mm EMERG SCREWSCROSSPINSELFT
1.2X4mm BONE SCREWSCROSSPINSELFT
S PROFYLE HAND T-PLATE,WIDE,8H
L PROFYLE HAND COMP T-PLATE,OBLI,RI,6H
PROFYLE/BONE SCREW 1.7X19mm S/T
PROFYLE/BONE SCREW 1.2X16mm S/T
1.7X13MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/M PLATE STR 16H
1.7X5MM LOCKING SCREWS,CROSS-PIN,SELF-T
1.4X9mm EMERG SCREWSCROSSPINSELFT
1.7X12mm BONE SCREWSCROSSPINSELFTAPPING
1.7X9MM LOCKING SCREWS,CROSS-PIN,SELF-T
PROFYLE/XS PLATE Y-NRW 5 HOLE
PROFYLE/EMERG BONE SCREW 1.9X12 S/T
2.3X10mm BONE SCREWSCROSSPINSELFTAPPING
M PROFYLE HAND COMP CONDY-PLATE,LE,6H
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)