FDA.reportPublic FDA data

SMV Scientific Non-Locking Plate

Primary DI
00816950024474
Brand
SMV Scientific Non-Locking Plate
Company
SMV SCIENTIFIC LLC
Model
304-16208
Catalog number
304-16208
Device description
208mm, Nonlocking Straight Reconstruction Plate
Published
2018-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816950024474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816950024474008169500244748169500244740816950024474

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length208Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-969-0639GUDID@smvscientific.com
1-800-969-0639quality@osteocentric.com

Regulatory Flags#

DUNS number
089645059
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100743000014.0 x 12mm Screw Super Fastener, ST340-2012340-20122023-06-12
008100743000184.0 x 14mm Screw Super Fastener, ST340-2014340-20142023-06-12
008100743000254.0 x 16mm Screw Super Fastener, ST340-2016340-20162023-06-12
008100743000324.0 x 18mm Screw Super Fastener, ST340-2018340-20182023-06-12
008100743000494.0 x 20mm Screw Super Fastener, ST340-2020340-20202023-06-12
008100743000564.0 x 22mm Screw Super Fastener, ST340-2022340-20222023-06-12
008100743000634.0 x 24mm Screw Super Fastener, ST340-2024340-20242023-06-12
008100743000704.0 x 26mm Screw Super Fastener, ST340-2026340-20262023-06-12
008100743000874.0 x 28mm Screw Super Fastener, ST340-2028340-20282023-06-12
008100743000944.0 x 30mm Screw Super Fastener, ST340-2030340-20302023-06-12
008100743001004.0 x 32mm Screw Super Fastener, ST340-2032340-20322023-06-12
008100743001174.0 x 34mm Screw Super Fastener, ST340-2034340-20342023-06-12
008100743001244.0 x 36mm Screw Super Fastener, ST340-2036340-20362023-06-12
008100743001314.0 x 38mm Screw Super Fastener, ST340-2038340-20382023-06-12
008100743001484.0 x 40mm Screw Super Fastener, ST340-2040340-20402023-06-12
008100743001554.0 x 42mm Screw Super Fastener, ST340-2042340-20422023-06-12
008100743001624.0 x 44mm Screw Super Fastener, ST340-2044340-20442023-06-12
008100743001794.0 x 46mm Screw Super Fastener, ST340-2046340-20462023-06-12
008100743001864.0 x 48mm Screw Super Fastener, ST340-2048340-20482023-06-12
008100743001934.0 x 50mm Screw Super Fastener, ST340-2050340-20502023-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118145284PURE PECTUSKLS-Martin L.P.HRS2026-05-25
00888118145291PURE PECTUSKLS-Martin L.P.HRS2026-05-25
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftBonebridge AGHRS2026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightBonebridge AGHRS2026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftBonebridge AGHRS2026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightBonebridge AGHRS2026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftBonebridge AGHRS2026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightBonebridge AGHRS2026-05-22
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
05055662971552Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
05055662971569Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
08809986480521CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-03-04
00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535091Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23