FDA Registration Active 🇺🇸 United States

LINDEMANN DRILL, SHORT 2.2MM

Reg #: 1833986 · FEI: 1000139987 · Expires 2025
Products
1
Proprietary Names
240
Establishment Types
1
Classifications
1

Registration Details

Registration Name
PRECISION EDGE SURGICAL PRODUCTS COMPANY
Registration Number
1833986
FEI Number
1000139987
Status
Active
Expiry Year
2025
Initial Importer
No
Address
415 W 12th Ave
City
Sault Sainte Marie
State
MI
ZIP
49783
Country
US

Regulatory Submissions

510(k) Number
K032303

Owner / Operator

Firm Name
Precision Edge Surgical Products Company
Operator Number
10042577
Address
415 West 12th Avenue
City
Sault Sainte Marie
State
MI
Postal Code
49783
Country
US
Correspondent
Angela Gorsuch

Products

Device Name Product Code
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE

Proprietary Names

LINDEMANN DRILL, SHORT 2.2MM ROUND DIAMOND BUR, 5.5MM SHORT FLUTED DRUM 7.5x7.9MM, X-LONG DRILL BIT W/4MM STOP, SH 1.3MM PREC. NEURO W/DIA COATED SHANK RD COARSE DIA BUR LONG 4MM TPD ROUTER SHORT (2.3X19MM) 7MM BARREL BUR LNG W/13MM STOP 6MM CORNERSTONE BUR BORING TOOL 15.6MMX10.4MM ROUND DIAMOND BUR COARSE 4mm DRILL BIT W/8MM STOP,MED 2MM RND DIAMOND BUR EXTD MED 4MM LINDEMANN DRILL, MEDIUM 2.2MM 7mm XX COARSE RND DIAMD BUR,SL FLUTED DRUM 7.5x7.9MM, LONG RD XXCOARSE DIA BUR, LG 6MM ROUND DIAMOND BUR (3mm) 2.5MM STRAIGHT ROUTER ROUND DIAMOND BUR, LONG 6MM 6MM RD FLUT BUR, X-LONG CARB WIRE PASS DRILL MED (1.1MM) DRILL BIT W/6MM STOP,SHT 2MM DRILL BIT W/6MM STOP,MED 1MM 0.5 MM ROUND FLUTED BUR RD XXCOARSE DIA BUR, MED 5MM 7.5x7.9mm XX CRS DIAMD DRUM,SL PEAR BUR LONG (6MM) RND DIAMND BUR EXTD LONG 3MM DRILL BIT W/4MM STOP,SHT 1.5MM NEURO DIAMOND DRIL 4.5 X 5.3mm ROUND DIAMOND BUR COARSE 6mm FLUTED DRUM 4.7x7.9MM, LONG ROUND DIAMOND BUR 2.5MM LONG ROUND DIAMOND BUR (5mm) 1.8X2.4MM NEURO DMD DRILL, LNG ROUND DIAMOND BUR 3.5MM MEDIUM 1.5 MM STRAIGHT ROUTER DRILL BIT W/11.6MM STOP 1.7MM DRILL BIT W/4MM STOP,MED 3.5MM 3X3.8MM DMD NEURO DRILL, LNG RD XXCOARSE DIA BUR, LG 4MM TAPERED DRILL, SHORT 2.3MM 1.5MM TAPERED ROUTER FLUTED DRUM 10.5x10.7MM, MED PREC NEURO DRILL W/COATD SHANK ROUND DIAMOND BUR, LONG 3MM 5120-50-64 - INVERTED CONE RND DIAMOND BUR EXTD MED 1MM DRILL BIT W/6MM STOP,SHT 1MM 3MM TAPERED ROUTER TAPERED DRILL MEDIUM(2.3MM) FLUTED DRUM 6x7.9MM, MEDIUM SIDE CUT DRUM 6.1x3.8MM, LONG ROUND DIAMOND BUR (6mm) 7MM BARREL BUR LNG W/15MM STOP ROUND DIAMOND BUR 4.5MM LONG FLUTED DRUM 4.7x16.4MM, LONG ROUND FLUTED BUR, X-LONG 9.1MM RND DIAMND BUR EXTD LONG 1MM 9.1x7.9mm XX CRS DIAMD DRUM,SL 2MM ROUND FLUTED BUR, AGGR RD COARSE DIA BUR LONG 6MM DRILL BIT W/4MM STOP,SHT 1MM FLUTED DRUM 12.3x10.7MM, XLONG TAPERED DRILL, MEDIUM 2.3MM 9MM CORNERSTONE BUR ROUND DIAMOND BUR, SHORT 2MM FLUTED DRUM 7.5x7.9MM, MEDIUM 4mm RND DIAMOND BUR,X-COARSE 3.1x19.1mm STRAIGHT ROUTER SL NEURO DIAMOND DRILL 3X3.8MM DRILL BIT W/8MM STOP,MED 1.5MM 3MM STRAIGHT ROUTER RND DIAMND BUR EXTD LONG 4MM RDN DIA BUR COARSE 1.5MM FLUTED DRUM 10.5x10.7MM, XLONG ROUND DIAMOND BUR, MED 2MM NEURO DIAMOND DRIL 4 X 5.1mm RND DIAMOND BUR EXTD MED 3MM .7mm ROUND DIAMOND BUR SIDE CUTTING DRILL, SHRT 2.3MM ROUND DIAMOND BUR, SHORT 7MM 2.5MM TAPERED ROUTER DRILL BIT W/8MM STOP,SHT 2MM ROUND DIAMOND BUR (4mm) ROUND DIAMOND BUR 4.5MM MEDIUM RND DIA BUR LNG XCOARSE 4MM 4mm XX COARSE RND DIAMD BUR,SL 7.5 mm ACORN BUR, SUPER LONG 0.7 MM ROUND FLUTED BUR ROUND FLUTED BUR, X-LONG 7.6MM RD COARSE DIA. BUR, MED 5MM 8mm ROUND FLUTED BUR, S-LONG DRILL BIT W/6MM STOP,SHT 1.5MM ROUND DIAMOND BUR, SHORT 6MM 4.5mm ROUND DIAMOND BUR ROUND DIAMOND BUR, MED 1MM BORING TOOL 9.5MMX10.4MM ROUND DIAMOND BUR, SHORT 1MM ROUND DIAMOND BUR, LONG 1MM 6 mm ACORN BUR, SUPER LONG .5mm ROUND DIAMOND BUR ROUND DIAMOND EXTRA CRSE 4.5MM 5160-10-60 W/3MM DIAM. DRILL BIT W/6MM STOP,MED 1.5MM DRILL BIT W/6MM STOP,MED 3.2MM ROUND DIAMOND BUR, 1.5MM MED ROUND DIAMOND EXTRA CRSE 5.5MM 5mm XX COARSE RND DIAMD BUR,SL RND DIAMOND BUR EXTD MED 2MM DRILL BIT W/4MM STOP,SHT 2MM ROUND DIAMOND BUR (2.5mm) ROUND DIAMOND BUR, 2.5MM SHORT TPD ROUTER SHORT (2.3X22MM) PEAR BUR SHORT (6MM) FLUTED DRUM,LONG(4.7MMX7.9MM) 9mm ROUND FLUTED BUR, S-LONG 9.1x7.9mm FLUTED DRUM, S-LONG DRILL BIT W/8MM STOP,SHT 1MM RD XXCRS DIA BUR, EXT LG 4MM 10.mm ROUND FLUTED BUR, S-LONG 1.6MM LD MED, ZIM 5091-212 8MM DIA. CORNERSTONE BUR ROUND DIAMOND BUR, MED 5MM RD COARSE DIA. BUR, MED 6MM 3mm ROUND FLUTED BUR, S-LONG 4.7x7.9mm FLUTED DRUM, S-LONG ROUND DIAMOND EXTRA CRSE 3.5MM 7MM CORNERSTONE BUR 9MM DIA. CORNERSTONE BUR ROUND DIAMOND BUR, SHORT 5MM RND DIAMND BUR EXTD LONG 2MM EIUS SYSTEM BUR RND FLUTED BUR EXTD LONG 1MM 5mm RND DIAMOND BUR,X-COARSE DRILL BIT W/8MM STOP,SHT 1.5MM ROUND DIAMOND BUR (2mm) RD XXCOARSE DIA BUR, LG 5MM ACORN BUR 6.1X8MM, X-LONG 8MM CORNERSTONE BUR FLUTED DRUM 9.1x7.9MM, LONG 10MM DIA. CORNERSTONE BUR DRILL BIT W/6MM STOP,MED 2.5MM FLUTED DRUM 9.1x4.4MM, MEDIUM WIRE PASS DRILL MED (2MM) STRAIGHT ROUTER 3.1x19.1MM XLG RD XXCRS DIA BUR, EXT LG 5MM 2.9X3.8MM NEURO DRILL, X-LONG RD COARSE DIA BUR LONG 5MM ROUND DIAMOND BUR COARSE 2MM 6mm ROUND FLUTED BUR, S-LONG DMD NEURO DRILL(3X3.8MM) MED STRAIGHT FLUTED BARREL BUR 3MM 4.5mm ROUND DIAMOND BUR,COARSE ROUND DIAMOND BUR COARSE 3mm ROUND DIAMOND BUR 5.5MM MEDIUM BORING TOOL LONG 9.5MMX10.4MM ROUND DIAMOND BUR (1mm) ROUND DIAMOND BUR, LONG 7MM FLUTED DRUM 6x7.9MM, LONG PEAR BUR LONG (4MM) ROUND DIAMOND BUR (1.5mm) FLUTED DRUM 4.7x16.4MM, MEDIUM 6mm RND DIAMOND BUR,X-COARSE RD COARSE DIA. BUR, MED 3MM FLUTED DRUM 9.1x7.9MM, MEDIUM SWNSN PILT PT BUR, 2MM SHORT RND DIAMND BUR EXTD LONG 5MM DRILL BIT W/4MM STOP,MED 1.5MM 2.2 mm LINDEMANN DRILL MIS COARSE ROUND DIA BUR 3MM 5mm ROUND FLUTED BUR, S-LONG ROUND DIAMOND BUR, SHORT 4MM ROUND DIAMOND BUR, LONG 2MM ROUND DIAMOND BUR 5.5MM LONG 6.5MM BARREL BUR,DIA,X-COURSE 2 MM STRAIGHT ROUTER FLUTED DRUM 4.7x7.9MM, X-LONG ROUND DIAMOND BUR 3.5MM LONG RD COARSE DIA. BUR, MED 4MM 4MM CORNERSTONE BUR DRILL BIT W/4MM STOP,MED 1MM 6mm XX COARSE RND DIAMD BUR,SL FLUTED DRUM 9.1x7.9MM, X-LONG TPD ROUTER 1.7mmX16mm 3MM TAPERED RND CRSE DIA ELITE RND FLTED BUR, EXTRA LNG 5MM DRILL TIP, MEDIUM 1.5MM TAPERED ROUTER,LG 2.3MMX30MM TPRD ROUTER EXLONG(2.3X22MM) ROUND DIAMOND BUR COARSE 1MM FLUTED DRUM 6x7.9MM, X-LONG NEURO DIAMOND DRIL 3.5 X 4.3mm RD XXCOARSE DIA BUR, MED 6MM NEURO DIAMOND DRIL 2 X 3.1mm NEURO DIAMOND DRIL 2.5 X 3.4mm 1.8X2.4MM NEURO DMD DRILL, MED 5MM CORNERSTONE BUR RND FLUTED BUR, EXTD MED 1MM ROUND FLUTED BUR, X-LONG 6MM ROUND DIAMOND BUR, SHORT 3MM FLUTED DRUM 9.1x4.4MM, LONG 5.5mm ROUND DIAMOND BUR,COARSE ACORN BUR 9.1X11.4MM, X-LONG ACORN BUR 7.5X9.5MM, X-LONG RND DIA BUR LNG X/COARSE 5MM 6.4MM INVERTED CONE BUR, MED. RD COARSE DIA BUR LONG 3MM 7MM DIA. CORNERSTONE BUR SWNSN PILT PT BUR, 4MM SHORT TPRD ROUTER EXLONG(2.3X3MM) ROUND DIAMOND BUR, MED 6MM STRAIGHT FLUTED BARREL BUR 4MM RD COURSE DIA. BUR, SHT 4mm 5MM DIA. CORNERSTONE BUR FLUTED DRUM 4.7x7.9MM, MEDIUM ROUND DIAMOND BUR COARSE 5mm FLUTED DRUM BUR(4.7MMX7.9MM) DRILL BIT W/8MM STOP,MED 2.5MM DRILL BIT W/6MM STOP,MED 2MM ROUND DIAMOND BUR 2.5MM MEDIUM BORING TOOL LONG 12.6MMX10.4MM NEURO DIAMOND DRL CRSE 3X3.8MM 3.5mm ROUND DIAMOND BUR 3.5mm ROUND DIAMOND BUR,COARSE 7mm ROUND FLUTED BUR, S-LONG 5.5mm ROUND DIAMOND BUR 2MM TAPERED ROUTER STRAIGHT FLUTED BARREL BUR 5MM DRILL BIT W/8MM STOP,MED 1MM FLUTED DRUM 10.5x10.7MM, LONG ROUND DIAMOND BUR, MED 7MM TPD ROUTER LONG (2.3X15.9MM) FLUTED DRUM 7.6x28.6MM, LONG 9 mm ACORN BUR, SUPER LONG NEURO DIAMOND DRIL 3 X 3.8mm 3MM DIA NEURO BUR, CRS, LONG 3mm RND DIAMND BUR, X-COARSE RND DIAMOND BUR EX COARSE2.5MM

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)